Otc - Active Ingredient
Active Ingredient (in each caplet)
acetaminophen 500 mg
Acetaminophen Tablet, Coated
FDA Label NDC 49035-755
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Acetaminophen (NDC 49035-755). 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 otc - active ingredient, inactive ingredient, otc - purpose, dosage & administration, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
inactive ingredients: hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*stearic acid, titanium dioxide
*may contain
Otc - Purpose
PAIN RELIEVER - FEVER REDUCER
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 6 caplets in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor. |
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. |
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
* Please review the disclaimer below.
