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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 caplet)

Acetaminophen .....................500 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 can cause serious health problems, including liver damage. In case of overdose, get medical help or contact poison control center 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 children 12 years and over

  • take 2 caplets every 6 hours as needed.
  • do not take more than 8 caplets in 24 hours
  • do not use more than 10 days unless directed by a doctor

children under 12 years

  • do not use this adult product in children under 12 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 the box is opened

Inactive Ingredients



Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide


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