Otc - Active Ingredient
Active Ingredient (in each tablets
acetaminophen 500 mg
Acetaminophen Tablet, Film Coated
FDA Label NDC 49483-341
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Labs Inc for the product Acetaminophen (NDC 49483-341). 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, warnings, indications & usage, otc - ask doctor, otc - stop use, otc - ask doctor/pharmacist, 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, stearic acid, titanium dioxide
Otc - Purpose
PAIN RELIEVER - FEVER REDUCER
Warnings
Warning: Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 caplets 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
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 - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Stop Use
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.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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