Pain Reliever Extra Strength
Pain Reliever Extra Strength is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Walgreens 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 20231009.
Generic: ACETAMINOPHEN
Manufacturer: Walgreens
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 0363-0278
Application: M013
Effective: 20231009
Active Ingredients: Active ingredient (in each 15 mL) Acetaminophen 500 mg
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning) do not take more then 4 doses in any 24 hours period measure only with dosing cup provided. Do not use any other dosing device mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 6 hours while symptoms last do not take more than 10 days unless directed by a doctor children under 12 years: do not use
Contraindications
Not available.
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks ever 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 nonprescription). 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 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 pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
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