Label: ACETAMINOPHEN- acetaminophen tablet extended release tablet, extended release

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

Drug Label Information

Updated February 24, 2025

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

  • ACTIVE INGREDIENT
    Active ingredient (in each caplet) Acetaminophen 650 mg
  • PURPOSE
    Purpose - Pain reliever/fever reducer
  • INDICATIONS & USAGE
    Uses - For Arthritis Pain - temporarily relieves minor aches and pains due to: minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common ...
  • 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 ...
  • 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 haveliver disease.
  • ASK DOCTOR/PHARMACIST
    Ask a doctor or pharmacist before use if you aretaking 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 right away. (1-800-222-1222). Quick medical attention is critical for ...
  • DOSAGE & ADMINISTRATION
    Directions - For Arthritis Pain - 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 ...
  • STORAGE AND HANDLING
    Other information - store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP
  • INACTIVE INGREDIENT
    Inactive ingredientscarnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide ...
  • OTHER SAFETY INFORMATION
    Questions or comments? Call - 1-877-290-4008
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Relabeled and Repackaged by: Enovachem PHARMACEUTICALS - Torrance, CA 90501
  • INGREDIENTS AND APPEARANCE
    Product Information