Label: ACETAMINOPHEN AND IBUPROFEN BACK PAIN- acetaminophen and ibuprofen tablet

  • NDC Code(s): 70010-213-26, 70010-213-31
  • Packager: Granules Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 9, 2025

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  • Active ingredients (in each caplet)
    Acetaminophen 250 mg - Ibuprofen 125 mg (NSAID**) **nonsteroidal anti-inflammatory drug
  • Purposes
    Pain reliever - Pain reliever
  • Uses
    • temporarily relieves minor aches and pains due to: o backache - o muscular aches - o minor pain of arthritis - o headache - o toothache - o menstrual cramps
  • 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 24 hours ...
  • Directions
    do not take more than directed - adults and children 12 years and over - take 2 caplets every 8 hours while symptoms persist - children under 12 years - ask a doctor - do not ...
  • Other information
    read all warnings and directions before use. Keep carton. store at 20 to 25°C (68 to 77°F) avoid excessive heat above 40°C (104°F)
  • Inactive ingredients
    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose ...
  • Questions or comments?
    call - 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
  • PRINCIPAL DISPLAY PANEL-18's Container Label
    NDC 70010-213-26 - †Compare to the Active Ingredients - of Advil - ® Dual Action Back Pain - Contains 2 Medicines - Acetaminophen and - Ibuprofen (NSAID) Tablets - 250 mg/125 ...
  • PRINCIPAL DISPLAY PANEL-18's Container Carton Label
    NDC 70010-213-26 - †Compare to the Active Ingredients - of Advil® Dual Action Back Pain - Contains 2 Medicines - Acetaminophen and - Ibuprofen (NSAID) Tablets - 250 ...
  • INGREDIENTS AND APPEARANCE
    Product Information