ACETAMINOPHEN ASPIRIN AND CAFFEINE

ACETAMINOPHEN ASPIRIN AND CAFFEINE is an FDA drug label for the active ingredient ACETAMINOPHEN, ASPIRIN AND CAFFEINE manufactured by Aurohealth LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231201.

Generic: ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Manufacturer: Aurohealth LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 58602-882

Application: ANDA211695

Effective: 20231201

Active Ingredients: Drug Facts Active ingredients (in each tablet) Acetaminophen USP 250 mg Aspirin USP 250 mg (NSAID*) Caffeine USP 65 mg *nonsteroidal anti-inflammatory drug

Indications & Usage

Use treats migraine

Dosage & Administration

Directions do not use more than directed adults: take 2 tablets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 tablets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor

Contraindications

Not available.

Warnings

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 2 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 than directed Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month. 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.

Adverse Reactions