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  5. Label Information: Extra Strength Taminol Acetaminophen

FDA Label for Extra Strength Taminol Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSES
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASKA DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    9. STOP USE AND ASK A DOCTOR IF 
    10. IF PREGNANCY OR BREAST-FEEDING ,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PACKAGE LABELING:

Extra Strength Taminol Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Viva Pharmaceutical Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient



Acetaminophen 500mg


Purposes



Pain reliever/Fever reducer


Uses



■ temporarily relieves minor aches & pain due to : ■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■muscular aches ■ premenstrual and menstrual cramps ■ temporarily reduces fever


Warnings



Liver warning: This product conatins acetaminophen.Severe liver damage may occur if yo take ■ more than 4,000 mg of acetaminophen in 24hr ■ with other drug conating acetaminophen ■ 3 or more alcholic drinks everyday while using this product

Allergy alert :Acetaminophen may cause severe skin reactions.Symptoms may include : ■ skin reddening ■ blisters ■ rash if a skin reaction occurs .stop use and seek medical help right away.


Do Not Use



■with any other drug containg acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetmniophen.ask doctor or pharmacist. ■ if you are ailergic to acetaminophen or any inactive ingrident in this product.


AskA Doctor Before Use If You Have



liver disease


Ask A Doctor Or Pharmacist Before Use If



you are taking blood thinner


Stop Use And Ask A Doctor If 



■ pain get worse or last more than 10 days ■ fever gets worse or lasts more than 3 days condition ■ new sympton occurs ■ redness or swelling present 


If Pregnancy Or Breast-Feeding ,



ask a healthcare professional before use.


Keep Out Of Reach Of Children.



Overdose warning: In case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away , Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



■ do not take more than directed (see overdose warning)

Adults and chiledren 12 years and over

 ■ take two caplets every 6 hour while symptoms last

 ■ do not take more than 8 caplets in 24hours unless directed by a doctor

 ■ do not take more than 10 days unless directed by a doctor

 Children under 12 years ■ ask a doctor


Other Information



■ store at 20°-25°C (68°-77°F)


Inactive Ingredients



Crospovidone , microcrystalline cellulose , Stearic acid , Silicon dioxide


Package Labeling:



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