Vitaphil Plus DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vitaphil Plus DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Vitaphil Plus DHA resources

• Vitaphil Plus DHA Use in Pregnancy & Breastfeeding
• Vitaphil Plus DHA Drug Interactions
• 0 Reviews for Vitaphil Plus DHA - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Vitaphil Plus DHA with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Anxetin

Anxetin may be available in the countries listed below.

Ingredient matches for Anxetin

Fluoxetine

Fluoxetine is reported as an ingredient of Anxetin in the following countries:

• Tunisia

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Anxetin in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Oman


• Qatar


• Romania


• Saudi Arabia


• Somalia


• Sudan


• United Arab Emirates


• Yemen

International Drug Name Search

Azax

Azax may be available in the countries listed below.

Ingredient matches for Azax

Azithromycin

Azithromycin is reported as an ingredient of Azax in the following countries:

• Turkey

International Drug Name Search

Veregen

Pronunciation: sin-a-CAT-ah-kins
Generic Name: Sinecatechins
Brand Name: Veregen

Veregen is used for:

Treating certain types of external genital or perianal warts.

Veregen is an extract of green tea leaves. Exactly how Veregen works is not known.

Do NOT use Veregen if:

• you are allergic to any ingredient in Veregen

Contact your doctor or health care provider right away if any of these apply to you.

Before using Veregen:

Some medical conditions may interact with Veregen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have warts inside the cervix, vagina, or anus


• if you have a weakened immune system (eg, HIV infection)


• if you have open wounds or broken or irritated skin in the treatment area


• if you are using other products on the treatment area

Some MEDICINES MAY INTERACT with Veregen. Because little, if any, of Veregen is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Veregen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Veregen:

Use Veregen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Veregen. Talk to your pharmacist if you have questions about this information.


• Wash your hands before and immediately after using Veregen.


• Gently apply a small amount of Veregen to each wart using the tips of your fingers. Completely cover each wart being treated, leaving a thin film of medicine on the wart.


• Be careful not to get Veregen in the vagina or the anus.


• Do not apply Veregen to open sores or broken skin.


• Do not wash Veregen off before you apply your next dose. If you will be taking a shower or bath, apply Veregen afterwards.


• Do not bandage, cover, or wrap the treated area; however, you may wear loose-fitting undergarments.


• Uncircumcised men with warts under the foreskin should pull back the foreskin and clean the area every day.


• Use Veregen on a regular schedule to get the most benefit from it. Using Veregen at the same times each day will help you remember to use it.


• Continue using Veregen until all of your genital or perianal warts have gone away unless your doctor tells you otherwise.


• If you miss a dose of Veregen, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Veregen.

Important safety information:

• Veregen is for the treatment of warts on the outside of the genitals or around the outside of the anus. Do not get Veregen in the eyes, nose, mouth, vagina, or anus. If you get it in any of these areas, rinse right away with cool water.


• Do not use more than the recommended dose or use for longer than 16 weeks without checking with your doctor. If your warts do not go away or they come back after treatment, contact your doctor.


• Veregen is not a cure for genital or perianal warts. Patients may still develop new warts during or after treatment with Veregen. Tell your doctor if you notice any new warts.


• Veregen does not stop the spread of genital or perianal warts to others. Talk with your doctor if you have questions about how to practice safe sex or how to prevent the spread of genital warts to others.


• Do not have sexual relations (eg, genital, anal, oral) while Veregen is on the skin. Carefully wash the medicine off the skin before having sex, as it may weaken condoms and diaphragms.


• If you use tampons, insert the tampon before applying Veregen. Be careful NOT to get Veregen in the vagina when inserting another tampon.


• If you develop blisters, ulcers, sores, or other severe irritation at the application site, wash Veregen off with mild soap and water. Contact your doctor for instructions.


• Do not expose the treated areas to sunlight, sunlamps, or tanning beds.


• Veregen may stain light-colored clothing and bedding. It is recommended that you wear dark-colored undergarments while you are using Veregen.


• Lab tests and medical exams, including a Pap smear, may be performed while you use Veregen. They may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Veregen should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Veregen while you are pregnant. It is not known if Veregen is found in breast milk after topical use. If you are or will be breast-feeding while you use Veregen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Veregen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, flaking, itching, pain, redness, scaling, or swelling at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, ulcers, sores, or other severe irritation at the application site; difficult or painful urination; groin or pelvic pain, swelling, or tenderness; unusual discharge or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Veregen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Veregen may cause harm if it is swallowed.

Proper storage of Veregen:

Store Veregen the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). You may also store it at room temperature up to 77 degrees F (25 degrees C). Do not freeze. Be sure the cap on the tube is tightly closed. Store away from heat and light. Do not use Veregen after the expiration date on the tube. Keep Veregen out of the reach of children and away from pets.

General information:

• If you have any questions about Veregen, please talk with your doctor, pharmacist, or other health care provider.


• Veregen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Veregen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Veregen resources

• Veregen Side Effects (in more detail)
• Veregen Use in Pregnancy & Breastfeeding
• Veregen Support Group
• 0 Reviews for Veregen - Add your own review/rating

• Veregen Prescribing Information (FDA)


• Veregen Monograph (AHFS DI)


• Veregen Advanced Consumer (Micromedex) - Includes Dosage Information


• Veregen Consumer Overview

Compare Veregen with other medications

• Condylomata Acuminata

Arthrofluor

Arthrofluor may be available in the countries listed below.

Ingredient matches for Arthrofluor

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Arthrofluor in the following countries:

• Hungary

International Drug Name Search

Hormodose

Hormodose may be available in the countries listed below.

Ingredient matches for Hormodose

Estradiol

Estradiol is reported as an ingredient of Hormodose in the following countries:

• Brazil

International Drug Name Search

A 20

A 20 may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for A 20

Aspirin

Acetylsalicylic Acid is reported as an ingredient of A 20 in the following countries:

• Poland

International Drug Name Search

Acute Myeloid Leukemia Medications

Drugs associated with Acute Myeloid Leukemia

The following drugs and medications are in some way related to, or used in the treatment of Acute Myeloid Leukemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Acute Myeloid Leukemia

• Acute Promyelocytic Leukemia (2 drugs)

Learn more about Acute Myeloid Leukemia

Micromedex Care Notes:

• Acute Myeloid Leukemia

Medical Encyclopedia:

• Acute myeloid leukemia

Harvard Health Guide:

• Symptoms and treatment for Acute Myeloid Leukemia (AML)

Drug List:

Cerubidine

Cytosar-U

Mylotarg

Oncovin

Tarabine-Pfs

Vincasar-Pfs

Gaisal

Gaisal may be available in the countries listed below.

Ingredient matches for Gaisal

Glutamine

Glutamine is reported as an ingredient of Gaisal in the following countries:

• Japan

Sodium Gualenate

Sodium Gualenate is reported as an ingredient of Gaisal in the following countries:

• Japan

International Drug Name Search

Telin

Telin may be available in the countries listed below.

Ingredient matches for Telin

Theophylline

Theophylline is reported as an ingredient of Telin in the following countries:

• Taiwan

International Drug Name Search

Bevigen

Bevigen may be available in the countries listed below.

Ingredient matches for Bevigen

Thiamine

Thiamine is reported as an ingredient of Bevigen in the following countries:

• Turkey

International Drug Name Search

Antigriphine

Antigriphine may be available in the countries listed below.

Ingredient matches for Antigriphine

Caffeine

Caffeine is reported as an ingredient of Antigriphine in the following countries:

• Belgium


• Luxembourg

Paracetamol

Paracetamol is reported as an ingredient of Antigriphine in the following countries:

• Belgium


• Luxembourg

International Drug Name Search

Ional Sodium

Ional Sodium may be available in the countries listed below.

Ingredient matches for Ional Sodium

Secobarbital

Secobarbital sodium salt (a derivative of Secobarbital) is reported as an ingredient of Ional Sodium in the following countries:

• Japan

International Drug Name Search

Ambroxol Arrow

Ambroxol Arrow may be available in the countries listed below.

Ingredient matches for Ambroxol Arrow

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol Arrow in the following countries:

• France

International Drug Name Search

A.A. Oxytocine

A.A. Oxytocine may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for A.A. Oxytocine

Oxytocin

Oxytocin is reported as an ingredient of A.A. Oxytocine in the following countries:

• Netherlands

International Drug Name Search

Ulobetasol

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D07AC21

CAS registry number (Chemical Abstracts Service)

0098651-66-2

Chemical Formula

C22-H27-Cl-F2-O4

Molecular Weight

428

Therapeutic Category

Adrenal cortex hormone, glucocorticoid

Chemical Name

21-Chloro-6α,9-difluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione

Foreign Names

• Ulobetasolum (Latin)
• Ulobetasol (German)
• Ulobétasol (French)
• Ulobetasol (Spanish)

Generic Names

• Ulobétasol (OS: DCF)
• Halobetasol Propionate (OS: USAN)
• BMY 30056 (IS: Bristol-Myers)
• CGP 14458 (IS)
• Miracorten (IS: Novartis)

Brand Names

• Halobetasol propionate
  Actavis, United States; Nycomed, United States; Perrigo, United States; Taro, United States



• Hobs
  Aamorb, India



• Hobs-S (Ulobetasol and Salicylic Acid)
  Aamorb, India



• Ultravate
  Ranbaxy, United States; Westwood-Squibb, Canada

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Chlorquin

Chlorquin may be available in the countries listed below.

Ingredient matches for Chlorquin

Chloroquine

Chloroquine phosphate (a derivative of Chloroquine) is reported as an ingredient of Chlorquin in the following countries:

• New Zealand

International Drug Name Search

Meblin

Meblin may be available in the countries listed below.

Ingredient matches for Meblin

Mebhydrolin

Mebhydrolin napadisilate (a derivative of Mebhydrolin) is reported as an ingredient of Meblin in the following countries:

• Taiwan

International Drug Name Search

Alarm

Alarm may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Alarm

Tetryzoline

Tetryzoline hydrochloride (a derivative of Tetryzoline) is reported as an ingredient of Alarm in the following countries:

• France

International Drug Name Search

Bupap Tablets

Dosage Form: tablet

Warning

HEPATOTOXICITY

ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.

Bupap Tablets Description

Butalbital and acetaminophen are supplied in tablet form for oral administration.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

C11H16N2O3 MW=224.26

Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2  MW=151.16

Each Bupap Tablet contains:

Butalbital …………………………………………….50 mg

Warning: May be habit-forming.

Acetaminophen ……………………………………...650 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid with FD&C Blue #1 Lake as coloring.

Bupap Tablets - Clinical Pharmacology

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital and acetaminophen. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-l-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital into either plasma or blood cells (see OVERDOSAGE for toxicity information).

Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. (See OVERDOSAGE for toxicity information).

Indications and Usage for Bupap Tablets

Bupap (butalbital and acetaminophen) Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.

Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Contraindications

This product is contraindicated under the following conditions:

• Hypersensitivity or intolerance to any component of this product.


• Patients with porphyria.

Warnings

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Bupap Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Bupap Tablets for patients with acetaminophen allergy.

Precautions

General

Bupap Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Information for Patients/Caregivers

• Do not take Bupap Tablets if you are allergic to any of its ingredients.


• If you develop signs of allergy such as a rash or difficulty breathing, stop taking Bupap Tablets and contact your healthcare provider immediately.


• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of butalbital and acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed: All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as a potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Drug Abuse and Dependence

Abuse and Dependence

Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Overdosage

Following an acute overdosage, toxicity may result from the barbiturate or the acetaminophen.

Signs and Symptoms

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

A single or multiple drug overdose with butalbital and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

USUAL DOSAGE

Oral: One tablet every four hours. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

How is Bupap Tablets Supplied

Bupap Tablets 50 mg/650 mg are supplied in bottles of 100 tablets, NDC# 0095-0240-01, and in bottles of 500 tablets, NDC# 0095-0240-05. Each tablet contains butalbital 50 mg (Warning: May be habit-forming) and acetaminophen 650 mg. Tablets are uncoated, blue, capsule-shaped and are debossed "59010/240" on the same side as the single-score.

Storage: Protect from light and moisture.

Store at 20° to 25°C (68°F to 77°F)[see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx only

Manufactured for:

ECR PHARMACEUTICALS

Richmond, VA 23255

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Code 612A00

Rev. 06/11

PRINCIPAL DISPLAY PANEL

BUPAP  butalbital and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0095-0240 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   CROSCARMELLOSE SODIUM   CROSPOVIDONE   FD&C BLUE NO. 1   POVIDONE   SILICON DIOXIDE   STARCH, CORN   STEARIC ACID

Product Characteristics Color BLUE Score 2 pieces Shape OVAL (CAPSULE) Size 18mm Flavor Imprint Code 59010;240 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0095-0240-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0095-0240-05 500 TABLET In 1 BOTTLE, PLASTIC None 3 0095-0240-09 1 TABLET In 1 POUCH None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA089988	12/01/1994

Labeler - ECR Pharmaceuticals Co., Inc. (831116350)

Registrant - Mikart, Inc. (030034847)

Establishment
Name	Address	ID/FEI	Operations
Mikart, Inc.		030034847	MANUFACTURE

Revised: 11/2011ECR Pharmaceuticals Co., Inc.

Azelaic Acid

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D10AX03

CAS registry number (Chemical Abstracts Service)

0000123-99-9

Chemical Formula

C9-H16-O4

Molecular Weight

188

Therapeutic Categories

Dermatological agent

Antiacne agent

Chemical Name

Nonanedioic acid

Foreign Names

• Acidum acelaicum (Latin)
• Azelainsäure (German)
• Acide azelaique (French)
• Acido azelaico (Spanish)

Generic Names

• Azelaic Acid (OS: USAN)
• Azélaïque (acide) (OS: DCF)
• Anchoic acid (IS)
• Lepargylic acid (IS)
• Nonandisäure (IS)
• ZK 62498 (IS: Schering)

Brand Names

• Acido Azelaico Farmoz
  Farmoz, Portugal



• Acnederm
  Ego, New Zealand



• Acne-Derm
  Unia, Poland



• Aknoren
  Herbacos, Czech Republic



• Aza 20
  Pharmacore Labs, Indonesia



• Azeclear
  United Pharmaceutical, Oman



• Azedose
  Alapis Pharma, Greece



• Azelac
  Med-One, Greece



• Azelaic Acid Novexal
  Novexal, Greece



• Azelaic Acid Proel
  Proel, Greece



• Azelan
  Schering, Brazil



• Azelaxine
  Velka, Greece



• Azelderm
  Kleva, Greece; Orva, Turkey



• Azelec
  Acme, Bangladesh



• Azelex
  Allergan, United States



• Cevigen
  Bros, Greece



• Chemilaic
  Farmanic Chemipharma, Greece



• Cutacelan
  Bayer, Peru; Schering, Argentina; Schering, Colombia



• Exazen
  Vocate, Greece



• Finacea
  Bayer, Sweden; Berlex, United States; CSL, Australia; Intendis, Bulgaria; Intendis, Denmark; Intendis, Spain; Intendis, France; Intendis, Iceland; Intendis, Italy; Intendis, Mexico; Intendis, Turkey; Intendis GmbH Berlin, Norway; Valeant, United Kingdom



• Finevin
  Berlex, United States



• Hascoderm
  Hasco, Poland



• Kenedril
  Biospray, Greece



• Noreskin
  Genepharm, Greece



• Opilet
  Rafarm, Greece



• Prevolac
  Cosmopharm, Greece



• Rino-Azetin
  UCI, Brazil



• Skinoderm
  Pharma Clal, Israel



• Skinoren
  Bayer, Belgium; Bayer, Switzerland; Bayer, Croatia (Hrvatska); Bayer, Sweden; Bayer, Taiwan; Bayer Schering, Finland; Bayer Schering, Greece; Bayer Schering, South Africa; CSL Biotherapies, New Zealand; Intendis, Austria; Intendis, Bulgaria; Intendis, Czech Republic; Intendis, Germany; Intendis, Denmark; Intendis, Estonia; Intendis, Spain; Intendis, France; Intendis, Hungary; Intendis, Italy; Intendis, Lithuania; Intendis, Luxembourg; Intendis, Latvia; Intendis, Malta; Intendis, Poland; Intendis, Russian Federation; Intendis, Turkey; Intendis GmbH Berlin, Norway; Meda, United Kingdom; Schering, United Arab Emirates; Schering, Bosnia & Herzegowina; Schering, Bahrain; Schering, Cyprus; Schering, Egypt; Schering, Georgia; Schering, Hong Kong; Schering, Ireland; Schering, Iraq; Schering, Iceland; Schering, Jordan; Schering, Kuwait; Schering, Lebanon; Schering, Luxembourg; Schering, Libya; Schering, Philippines; Schering, Portugal; Schering, Qatar; Schering, Romania; Schering, Serbia; Schering, Saudi Arabia; Schering, Sudan; Schering, Singapore; Schering, Slovenia; Schering, Thailand; Schering, Yemen



• Sonalent
  Chrispa, Greece



• Zelaika
  Intendis, Spain



• Zelface
  Ferron, Indonesia



• Zelicrema
  Biomedica-Chemica, Greece



• Zeliderm
  Viñas, Spain



• Zeliris
  Caprifarmindo, Indonesia



• Zorkenil
  Uni-Pharma, Greece



• Zumilin
  Farmedia, Greece

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Anthelpor

Anthelpor may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Anthelpor

Levamisole

Levamisole is reported as an ingredient of Anthelpor in the following countries:

• United Kingdom

International Drug Name Search

A-cnotren

A-cnotren may be available in the countries listed below.

Ingredient matches for A-cnotren

Isotretinoin

Isotretinoin is reported as an ingredient of A-cnotren in the following countries:

• Greece

International Drug Name Search

Apo-Triazo

Apo-Triazo may be available in the countries listed below.

Ingredient matches for Apo-Triazo

Triazolam

Triazolam is reported as an ingredient of Apo-Triazo in the following countries:

• Canada

International Drug Name Search

Colisultrix

Colisultrix may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Colisultrix

Colistin Sulfate

Colistin sulfate (a derivative of Colistin) is reported as an ingredient of Colisultrix in the following countries:

• France

Trimethoprim

Trimethoprim is reported as an ingredient of Colisultrix in the following countries:

• France

International Drug Name Search

Piperacillin / Tazobactam Orchid Europe Ltd

Piperacillin/Tazobactam Orchid Europe Ltd may be available in the countries listed below.

Ingredient matches for Piperacillin/Tazobactam Orchid Europe Ltd

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Piperacillin/Tazobactam Orchid Europe Ltd in the following countries:

• Germany


• Sweden

Tazobactam

Tazobactam sodium salt (a derivative of Tazobactam) is reported as an ingredient of Piperacillin/Tazobactam Orchid Europe Ltd in the following countries:

• Germany


• Sweden

International Drug Name Search

Duphatrim

Duphatrim may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Duphatrim

Sulfadiazine

Sulfadiazine is reported as an ingredient of Duphatrim in the following countries:

• United Kingdom

Trimethoprim

Trimethoprim is reported as an ingredient of Duphatrim in the following countries:

• United Kingdom

International Drug Name Search

Cold Multi-Symptom Severe Daytime Cool Ice

Generic Name: acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin)

Brand Names: Cold & Cough PE, Cold Head Congestion Severe Daytime, Cold Multi-Symptom Severe Daytime Cool Ice, Mucinex Children's Multi-Symptom Cold & Fever, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold & Flu Severe, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime

What is Cold Multi-Symptom Severe Daytime Cool Ice (acetaminophen, dextromethorphan, guaifenesin, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, guaifenesin, and phenylephrine is used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, guaifenesin, and phenylephrine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  cough with mucus, or cough caused by emphysema or chronic bronchitis.

  
  

It is not known whether acetaminophen, dextromethorphan, guaifenesin, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, fast, slow, or uneven heart rate;

  
  


• 
  

  severe dizziness, feeling like you might pass out;

  
  


• 
  

  mood changes, confusion, hallucinations;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  fever;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  mild headache;

  
  


• 
  

  mild nausea, diarrhea, upset stomach;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  feeling nervous, restless, irritable, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

• 
  

  leflunomide (Arava);

  
  


• 
  

  tapentadol (Nucynta);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  migraine headache medicine;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cold Multi-Symptom Severe Daytime Cool Ice resources

• Cold Multi-Symptom Severe Daytime Cool Ice Side Effects (in more detail)
• Cold Multi-Symptom Severe Daytime Cool Ice Use in Pregnancy & Breastfeeding
• Cold Multi-Symptom Severe Daytime Cool Ice Drug Interactions
• Cold Multi-Symptom Severe Daytime Cool Ice Support Group
• 0 Reviews for Cold Multi-Symptom Severe Daytime Cool Ice - Add your own review/rating

Compare Cold Multi-Symptom Severe Daytime Cool Ice with other medications

• Cold Symptoms
• Influenza

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dextromethorphan, guaifenesin, and phenylephrine.

See also: Cold Multi-Symptom Severe Daytime Cool Ice side effects (in more detail)

Flebon

Flebon may be available in the countries listed below.

Ingredient matches for Flebon

Diosmin

Diosmin is reported as an ingredient of Flebon in the following countries:

• Argentina

International Drug Name Search

Atenolol Mundogen

Atenolol Mundogen may be available in the countries listed below.

Ingredient matches for Atenolol Mundogen

Atenolol

Atenolol is reported as an ingredient of Atenolol Mundogen in the following countries:

• Spain

International Drug Name Search

Cyclessa

In the US, Cyclessa (desogestrel/ethinyl estradiol systemic) is a member of the drug class contraceptives and is used to treat Abnormal Uterine Bleeding, Birth Control, Endometriosis, Gonadotropin Inhibition and Polycystic Ovary Syndrome.

US matches:

• Cyclessa

Ingredient matches for Cyclessa

Desogestrel

Desogestrel is reported as an ingredient of Cyclessa in the following countries:

• United States

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Cyclessa in the following countries:

• United States

International Drug Name Search

Anzemet

In the US, Anzemet (dolasetron systemic) is a member of the drug class 5HT3 receptor antagonists and is used to treat Nausea/Vomiting - Chemotherapy Induced and Nausea/Vomiting - Postoperative.

US matches:

• Anzemet


• Anzemet Tablets


• Anzemet Injection

Ingredient matches for Anzemet

Dolasetron

Dolasetron mesilate (a derivative of Dolasetron) is reported as an ingredient of Anzemet in the following countries:

• Australia


• Brazil


• Canada


• France


• Greece


• Italy


• Luxembourg


• Malta


• Mexico


• Poland


• Romania


• Tunisia


• United States


• Venezuela

Dolasetron mesilate monohydrate (a derivative of Dolasetron) is reported as an ingredient of Anzemet in the following countries:

• Switzerland


• United States

International Drug Name Search

Myocrisin

Myocrisin may be available in the countries listed below.

UK matches:

• Myocrisin Injection 10% (SPC)
• Myocrisin Injection 2% (SPC)

Ingredient matches for Myocrisin

Sodium Aurothiomalate

Sodium Aurothiomalate is reported as an ingredient of Myocrisin in the following countries:

• Australia


• Denmark


• Finland


• Ireland


• New Zealand


• Sweden


• Thailand


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Axinotecan

Axinotecan may be available in the countries listed below.

Ingredient matches for Axinotecan

Irinotecan

Irinotecan hydrochloride trihydrate (a derivative of Irinotecan) is reported as an ingredient of Axinotecan in the following countries:

• Germany

International Drug Name Search

Pulmoxcel

Pulmoxcel may be available in the countries listed below.

Ingredient matches for Pulmoxcel

Terbutaline

Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Pulmoxcel in the following countries:

• Philippines

International Drug Name Search

Etoposide-Mayne

Etoposide-Mayne may be available in the countries listed below.

Ingredient matches for Etoposide-Mayne

Etoposide

Etoposide is reported as an ingredient of Etoposide-Mayne in the following countries:

• Luxembourg

International Drug Name Search