Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG. It is labelled by Health Pharma USA LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71679-307, 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 250 MG ASPIRIN 250 MG CAFFEINE 65 MG are most often described in connection with: temporarily relieves, minor aches, pains due, headache cold, arthritis muscular, sinusitis toothache, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ sinusitis ■ toothache ■ premenstrual and menstrual cramps

Directions Directions ■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over ■ take 2 tablets every 6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

Warning Warnings Reye's syndrome: Children and teenagers who have or are recovering 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 an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ shock ■ facial swelling ■ asthma (wheezing). Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 tablets 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. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

What is Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg used for?
Uses Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ sinusitis ■ toothache ■ premenstrual and menstrual cramps

Who makes Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg?
Health Pharma USA LLC is the labeler of record for Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg.

What form does Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 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 250 mg Aspirin 250 mg Caffeine 65 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.

Has Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg 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.