Aspirin 81 mg

Aspirin 81 mg is an FDA-registered drug product whose active ingredient is ASPIRIN. It is labelled by HAWAII REPACK, INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85534-0042, application M013, label effective 20260828. It is one of 106 FDA drug label records sharing the active ingredient ASPIRIN. 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 ASPIRIN are most often described in connection with: temporarily relieves, minor aches, delayed action, product will, prodice fast, relief headaches, symptoms needing, doctor about. 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 Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg Aspirin

Directions - Drink a full glass of water with each dose - adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor - children under 12 years: consult a doctor

Warnings Reye's syndrome: Children and teenagers who have or are recoving from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be early sign of Reye's syndrome, a rare but serious illness.

FDA lists 106 drug label records with ASPIRIN 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.

1 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 Aspirin 81 mg used for?
Uses temporarily relieves minor aches and pains Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg Aspirin

Who makes Aspirin 81 mg?
HAWAII REPACK, INC. is the labeler of record for Aspirin 81 mg. 106 FDA label records share the active ingredient ASPIRIN, 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 Aspirin 81 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 Aspirin 81 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 ASPIRIN?
Yes. 106 FDA drug label records list ASPIRIN 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 Aspirin 81 mg been recalled?
1 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.