Label: PAIN RELIEVER AND FEVER REDUCER- acetaminophen tablet, film coated

  • NDC Code(s): 68210-4225-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2024

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

  • Drug Facts
  • Active Ingredient (in each tablet)
    Acetaminophen 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 • premenstrual and menstrual cramps ...
  • Warning
    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 ...
  • 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 ...
  • Ask a doctor before use if you have
    liver disease
  • Ask a doctor or pharmacist before use if you are 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 ...
  • Directions
    do not take more than directed (see overdose warning) adults & children 12 years & over• take 2 tablets every 6 hours while symptoms last - • do not ...
  • Other information
    • store between 20–25°C (68–77°F)
  • Inactive ingredients
    Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide
  • Inactive ingredients
    1-888-333-9792
  • Distributed by:
    Cabinet Health P.B.C.
  • Principal Display Panel
    Pain Reliever Fever Reducer Jar
  • INGREDIENTS AND APPEARANCE
    Product Information