Duralgina Extra Strength

Duralgina Extra Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Menper Distributors, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 53145-830, application M013, label effective 20260615. 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: temporary relief, minor aches, pains associated, headache muscular, arthritis pain, menstrual cramps, common cold, backaches toothaches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of minor aches and pains associated with: headache muscular aches minor arthritis pain menstrual cramps common cold backaches toothaches temporarily reduces fever

Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 tablets every 4-6 hours as needed. Do not take more than 12 tablets in 24 hours, unless directed by a doctor. children ages 6-11: take 1 tablet every 4-6 hours as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor. under 6 years of age: ask a doctor.

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours, with other drugs containing acetaminophen, 3 or more alcoholic drinks every day.

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.

What is Duralgina Extra Strength used for?
Uses For the temporary relief of minor aches and pains associated with: headache muscular aches minor arthritis pain menstrual cramps common cold backaches toothaches temporarily reduces fever

Who makes Duralgina Extra Strength?
Menper Distributors, Inc. is the labeler of record for Duralgina Extra Strength. 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 Duralgina Extra Strength 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 Duralgina Extra Strength 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 Duralgina Extra Strength been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.