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 Cvs Health Corp. 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 325 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
• temporarily relieves minor aches and pains due to:
o headache
o the common cold
o backache
o minor pain of arthritis
o toothache
o muscular aches
o premenstrual and menstrual cramps
• temporarily reduces fever
Warnings
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 12 tablets in 24 hours, which is the maximum daily amount
• 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.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop using and ask a doctor if
• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
Do not take more than directed
adults and children 12 years and over | • take 2 tablets (650 mg) every 4 to 6 hours while symptoms last
|
children 6 years to under 12 years | • take 1 tablet (325 mg) every 4 to 6 hours while symptoms last
• do not take more than 5 tablets (1,625 mg) in 24 hours • do not use for more than 5 days unless directed by a doctor |
children under 6 years | ask a doctor |
Other Safety Information
Other information
• SODIUM FREE
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
Inactive Ingredient
Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient
* Please review the disclaimer below.