Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 49483-341-01, 49483-341-10, 49483-341-20, 49483-341-50
  • Packager: TIME CAP LABS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • DRUG FACTS
  • ACTIVE INGREDIENT
    Active ingredient (in each caplet) Acetaminophen 500 mg
  • PURPOSE
    Purpose - Pain reliever/fever reducer
  • 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 ...
  • 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 ...
  • DO NOT USE
    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 ...
  • ASK DOCTOR
    Ask a doctor before use if you have liver disease
  • ASK DOCTOR/PHARMACIST
    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
  • STOP USE
    Stop using 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 ...
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN
    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 ...
  • DOSAGE & ADMINISTRATION
    Directions: do not take more than directed (see overdose waning) adults and children 12 years and over: • take 2 caplets every 6 hours while symptoms last - • do not take more than 6 ...
  • OTHER INFORMATION
    Other information - SODIUM FREE - store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F) use by expiration date on package
  • INACTIVE INGREDIENT
    Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide - *may contain this ingredient
  • QUESTIONS
    Questions or comments?Call - 1-877-290-4008
  • PRINCIPAL DISPLAY PANEL
    341R-Timely-APAP500-200s-label ...
  • INGREDIENTS AND APPEARANCE
    Product Information