Label: ACETAMINOPHEN tablet

  • NDC Code(s): 69848-003-10, 69848-003-17, 69848-003-24
  • Packager: Granules USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient
    (in each Caplet) Acetaminophen, USP 500 mg
  • Purpose
    Pain reliever/fever reducer
  • Uses
    ■ temporarily relieves minor aches and pains due to: ■ the common cold ■ headache - ■ backache ■ minor pain of arthritis - ■ toothache ■ muscular aches ...
  • 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 ...
  • 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 ...
  • 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 the reach of children.
  • Overdose warning
    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Promt medical attention is critical for adults as well as for children even if you do not ...
  • Directions
    ■ do not take more than directed (see overdose warning) adults and children 12 years and over - ■ take 2 caplets every 6 hours while symptoms last - ■ do not take more than 6 caplets in 24 hours ...
  • Other information
    ■ store between 20-25°C (68-77°F).See USP Controlled Room Temperature - ■ avoid high humidity - ■ see end panel for lot number and expiration date
  • Inactive ingredients
    hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
  • Questions or comments?
    call - 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
  • PRINCIPAL DISPLAY PANEL
    24 count ...
  • INGREDIENTS AND APPEARANCE
    Product Information