Acetaminophen 500mg ES
Acetaminophen 500mg ES is an FDA drug label for the active ingredient ACETAMINOPHEN 500MG manufactured by Allegiant Health 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 20190108.
- Generic name
- ACETAMINOPHEN 500MG
- Manufacturer
- Allegiant Health
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69168-011
- Application
- M013
- Label effective
- 20190108
Active ingredients
Indications & Usage
Uses temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache arthritis menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not use more than directed (see overdose warning) adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours. Do not use more than 10 days unless directed by a doctor children under 12 years of age: do not use this extra strength product; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Contraindications
Not available.
Warnings
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts for more than 10 days pain get worse or lasts more than 5 days in children under 12 years fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present a rare sensitivity reaction occurs You may report side effects to 1-888-952-0050 If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adverse Reactions
Not available.