ACETAMINOPHEN 500 MG

ACETAMINOPHEN 500 MG is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by A-S Medication Solutions taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50090-7961, application M013, label effective 20260522. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily relieves, minor aches, pains due, headache muscular, pain arthritis, common cold, toothache premenstrual, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions do not take more than directed (see overdose warning) adults & children 12 years and over: take 1 tablet every 3-4 hours or 2 tablets every 6 hours while symptoms last do not take more than 8 tablets in 24 hours children under 12 years: do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen 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

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is ACETAMINOPHEN 500 MG used for?
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

Who makes ACETAMINOPHEN 500 MG?
A-S Medication Solutions is the labeler of record for ACETAMINOPHEN 500 MG. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ACETAMINOPHEN 500 MG come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ACETAMINOPHEN 500 MG prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ACETAMINOPHEN 500 MG been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.