FDA Label for Acetaminophen
View Indications, Usage & Precautions
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 .............................. 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 (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 |
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children under 12 years |
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Other Information
- store between 20°- 25°C (68°- 77°F)
- do not use if the box is
Inactive Ingredients
povidone, pregelatinized starch, stearic acid
*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®
* Please review the disclaimer below.