Acetaminophen , Caffeine and pyrilamine maleate

Acetaminophen , Caffeine and pyrilamine maleate is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE. It is labelled by Softgel Healthcare Pvt Ltd taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 35916-0710, application M013, label effective 20260427. 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 , CAFFEINE AND PYRILAMINE MALEATE are most often described in connection with: temporary relief, symptoms associated, menstural periods, cramps bloating, waterweight gain, headache backache, muscle aches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for the temporary relief of these symptoms associated with menstural periods: • cramps • bloating • waterweight gain • headache • backache • muscle aches • fatigue

Directions • do not take more than the recommended dose • adults and children 12 years and older: take 2 softgel with water • repeat every 6 hours as needed • do not exceed 6 softgel per day • children under 12 years: consult a doctor

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 softgel in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • hives • blisters • rash • skin reddening • facial swelling • asthma (wheezing) • shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

What is Acetaminophen , Caffeine and pyrilamine maleate used for?
Uses for the temporary relief of these symptoms associated with menstural periods: • cramps • bloating • waterweight gain • headache • backache • muscle aches • fatigue

Who makes Acetaminophen , Caffeine and pyrilamine maleate?
Softgel Healthcare Pvt Ltd is the labeler of record for Acetaminophen , Caffeine and pyrilamine maleate.

What form does Acetaminophen , Caffeine and pyrilamine maleate 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 , Caffeine and pyrilamine maleate 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.

Has Acetaminophen , Caffeine and pyrilamine maleate 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.