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 Target Corporation. 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.
Otc - Active Ingredient
Active Ingredient (in each tablet)
acetaminophen 500 mg
Inactive Ingredient
hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate* stearic acid, titanium dioxide
*may contain this ingredient
Otc - Purpose
PAIN RELIEVER - FEVER REDUCER
Indications & Usage
Uses: temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps, temporarily reduces fever.
Dosage & Administration
Directions: Do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 caplets every 4 to 6 hours while symptoms last
do not take more than 8 caplets in 24 hours
do not take for more than 10 days unless directed by a doctor
children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
•
more than 4,000 mg of acetaminophen in 24 hours
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label.Principal Display Panel
* Please review the disclaimer below.