Label: DUAL ACTION PAIN RELIEVER- acetaminophen and ibuprofen tablet, film coated

  • NDC Code(s): 83324-178-44
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 3, 2024

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  • Active ingredients (in each caplet)
    Acetaminophen, USP 250 mg - Ibuprofen, USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
  • Purposes
    Pain reliever - Pain reliever
  • INDICATIONS & USAGE
    Uses - temporarily relieves minor aches and pains due to: headache - toothache - backache - menstrual cramps - muscular aches - minor pain of arthritis
  • WARNINGS
    Warnings - Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen - more than 6 caplets in ...
  • DOSAGE & ADMINISTRATION
    Directions - ■ do not take more than directed - adults and children 12 years and over■ take 2 caplets every 8 hourswhile symptoms persist - children under 12 years■ ask a ...
  • STORAGE AND HANDLING
    Other information - each caplet contains: sodium 3 mg - read all warnings and directions before use. store at 20°C to 25°C (68°F to 77°F) avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT
    Inactive ingredients - carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline ...
  • QUESTIONS
    Questions or comments? call toll-free - 1-888-235-2466
  • SPL UNCLASSIFIED SECTION
    Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage. DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR ...
  • PRINCIPAL DISPLAY PANEL
    NDC 83324-178-44 - QUALITY CHOICE - ***Compare to the Active Ingredients in - Advil® Dual Action with Acetaminophen - Dual Action Pain Reliever - Acetaminophen and Ibuprofen (NSAID ...
  • INGREDIENTS AND APPEARANCE
    Product Information