Acetaminophen 325mg RS
Acetaminophen 325mg RS is an FDA drug label for the active ingredient ACETAMINOPHEN 325MG 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 20190107.
- Generic name
- ACETAMINOPHEN 325MG
- Manufacturer
- Allegiant Health
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69168-010
- Application
- M013
- Label effective
- 20190107
Active ingredients
Indications & Usage
Uses temporary relief of minor aches and pains associated with: headache backache muscular aches minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning) Adults and children 12 years and over: Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 10 tablets in 24 hours, unless directed by a doctor Do not use for more than 10 days unless directed by a doctor Children 6-11 years of age: Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours. Do not use for more than 5 days unless directed by a doctor Children under 6 years: ask a doctor
Contraindications
Not available.
Warnings
Warnings Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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 with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin is a child with pain of arthritis Stop use and ask a doctor if Adult’s pain gets worse or lasts more than 10 days Child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children Overdose warning : In case of overdose, get medical help or contact a 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.