8 hr Pain Relief
8 hr Pain Relief is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by DOLGENCORP, INC. 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 20230420.
Generic: ACETAMINOPHEN
Manufacturer: DOLGENCORP, INC.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 55910-895
Application: ANDA215486
Effective: 20230420
Active Ingredients: Active ingredient (in each caplet) Acetaminophen 650 mg
Indications & Usage
Uses • temporarily relieves minor aches and pains due to: o muscular aches o backache o minor pain of arthritis o toothache o premenstrual and menstrual cramps o headache o the common cold • temporarily reduces fever
Dosage & Administration
Directions Do not take more than directed. See overdose warning adults and children 12 years and over • take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split, or dissolve • do not take more than 6 caplets in 24 hours • do not use for 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 6 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 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 more than 10 days • fever gets worse or lasts 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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.
More from same ingredient
8 Hour Arthritis Pain
AMERISOURCE BERGEN
8 Hour Arthritis Pain
MARC GLASSMAN, INC.
8 Hour Pain Relief
STRATEGIC SOURCING SERVICES LLC
8 hr Arthritis Pain Relief
DOLGENCORP, INC.
ACETAMINOPHEN
TIME CAP LABORATORIES, INC
APAP
Advance Pharmaceutical Inc.
APAP
Richmond Pharmaceuticals, Inc.