GenCare Headache Relief

GenCare Headache Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, ASPIRIN, CAFFEINE. It is labelled by Pioneer Life Sciences, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72090-007, application M013, label effective 20260809. It is one of 27 FDA drug label records sharing the active ingredient ACETAMINOPHEN, ASPIRIN, CAFFEINE. 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, ASPIRIN, CAFFEINE are most often described in connection with: temporarily relieves, minor aches, pains due, headache cold, arthritis muscular, toothache premenstrual, menstrual cramps. 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 due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & menstrual cramps

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

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: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rash If a skin reaction occurs, stop use and seek medical help right away. Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •facial swelling •asthma (wheezing) •shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 8 caplets 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 than 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 heart beat. Do not use •if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

FDA lists 27 drug label records with ACETAMINOPHEN, ASPIRIN, CAFFEINE 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 GenCare Headache Relief used for?
Uses: temporarily relieves minor aches and pains due to: •headache •a cold •arthritis •muscular aches •toothache •premenstrual & menstrual cramps

Who makes GenCare Headache Relief?
Pioneer Life Sciences, LLC is the labeler of record for GenCare Headache Relief. 27 FDA label records share the active ingredient ACETAMINOPHEN, ASPIRIN, CAFFEINE, 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 GenCare Headache Relief 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 GenCare Headache Relief 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, ASPIRIN, CAFFEINE?
Yes. 27 FDA drug label records list ACETAMINOPHEN, ASPIRIN, CAFFEINE 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 GenCare Headache Relief 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.