Acetaminophen Extended-Release Tablets, 650 mg

Acetaminophen Extended-Release Tablets, 650 mg is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by MARKSANS PHARMA LIMITED taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 25000-071, application ANDA215486, label effective 20231017. 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: acetaminophen extended-release, tablets usp, pain temporarily, relieves minor, pains due, muscular aches, menstrual cramps, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever. Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever

Directions Do not take more than directed. See overdose warning adults and children 12 years and over take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split, or dissolve do not take more than 6 caplets in 24 hours do not use for 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) The FDA approved Dissolution methods differ from USP do not use if carton is opened. Do not use if foil inner seal is broken or missing

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 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. 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.

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.

3 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 Extended-Release Tablets, 650 mg used for?
Uses Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever. Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain temporarily relieves minor aches and pains due to: …

Who makes Acetaminophen Extended-Release Tablets, 650 mg?
MARKSANS PHARMA LIMITED is the labeler of record for Acetaminophen Extended-Release Tablets, 650 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 Extended-Release Tablets, 650 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 Extended-Release Tablets, 650 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 Extended-Release Tablets, 650 mg been recalled?
3 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.