Active Ingredient
(in each tablet)
Acetaminophen, USP 500 mg
Acetaminophen
FDA Label NDC 68016-657
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium,llc for the product Acetaminophen (NDC 68016-657). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000mg 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.
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 other inactive ingredients in this product
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 Use And Ask A Doctor If
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of The Reach Of Children
Keep out of the reach of children.
Overdose Warning
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
■ take 2 tablets every 4 to 6 hours while symptoms last
■ do not take more than 6 tablets in 24 hours
■ do not take more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
Other Information
■ store between 20-25°C (68-77°F)
■ do not use if carton is opened or neck wrap or foil inner seal imprinted is broken or missing
Inactive Ingredients
hydroxypropyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
call 1-844-724-7347 Mon-Fri 9:00 AM to 4:30 PM EST
Package Label.Principal Display Panel
100 (500mg)
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