Label: ACETAMINOPHEN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 1, 2025

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  • ACTIVE INGREDIENT (IN EACH CAPLET)
    Acetaminophen  650 mg
  • PURPOSE
    Pain reliever/fever reducer
  • USES
    • temporarily relieves minor aches and pains due to:     • minor pain of arthritis -     • muscular aches -     • backache -     • premenstrual and menstrual cramps ...
  • 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 ...
  • Do not use
    • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are ...
  • 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 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 ...
  • 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 ...
  • DIRECTIONS
    •  do not take more than directed (see overdose warning)  adults • take 2 caplets every 8 hours with water -  • swallow whole; do not crush, chew, split or dissolve -  • do ...
  • OTHER INFORMATION
    • store between 20-25°C (68-77°F) • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
  • INACTIVE INGREDIENTS
    hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
  • QUESTIONS ?
    call toll free - 1-844-912-4012
  • PRINCIPAL DISPLAY PANEL
    NDC 37835-512-01 - Compare to the active ingredients in Tylenol - ® 8 HR Arthritis Pain* Acetaminophen Extended-release Tablets - 650 mg - Pain reliever/fever reducer - For the Temporary Relief ...
  • INGREDIENTS AND APPEARANCE
    Product Information