Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60

Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS. It is labelled by Health Pharma USA LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71679-312, application M013, label effective 20260708. 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 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETS are most often described in connection with: temporary relief, symptoms associated, menstrual periods, cramps bloating, water-weight gain, headache backache, muscle aches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses: ■ for the temporary relief of these symptoms associated with menstrual periods: ■ cramps ■ bloating ■ water-weight gain ■ headache ■ backache ■ muscle aches ■ fatigue

Directions Directions ■ do not exceed recommended dosage. ■ adults and children 12 years and over: take 2 tablets with water. Repeat every 6 hours, as needed do not exceed 6 tablets per day ■ children under 12 years: consult a doctor

Warning Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 6 tablets 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 warning: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock. If a skin or general allergic reaction occurs, stop use and seek medical help right away.

What is Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 used for?
Uses Uses: ■ for the temporary relief of these symptoms associated with menstrual periods: ■ cramps ■ bloating ■ water-weight gain ■ headache ■ backache ■ muscle aches ■ fatigue

Who makes Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60?
Health Pharma USA LLC is the labeler of record for Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60.

What form does Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60 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 Pyrilamine Maleate 15 and Caffeine 60 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 500 Pyrilamine Maleate 15 and Caffeine 60 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.