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 325mg
Inactive Ingredient
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
Otc - Purpose
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
DOSAGE & ADMINISTRATION
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets (1,000 mg) every 6 hours while symptoms last
do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor
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 dose (overdose) of acetaminophen and may cause liver damage
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
•
more than 12 tablets 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.
* Please review the disclaimer below.