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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. USES
    3. WARNINGS
    4. OVERDOSE WARNING:
    5. DIRECTIONS: DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Cispharma, 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 (in each tablet)

Acetaminophen .............................. 325 mg


Uses



Temporarily relieves minor aches and pains due to:

  • headache
  • the common cold
  • backache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • premenstrual and menstrual cramps

    • temporarily reduces fever


Warnings



Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.


Overdose Warning:



Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 children 12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours
  • do not use more than 10 days unless directed by a doctor

children 6 years to 11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours

children under 6 years

  • do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information



  • store between 20°- 25°C (68°- 77°F)
  • do not use if carton is opened

Inactive Ingredients



povidone, pregelatinized starch, stearic acid


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