Label: IBUPROFEN tablet, film coated

  • NDC Code(s): 0904-7912-24, 0904-7912-51, 0904-7912-59
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 6, 2024

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  • Active ingredient (in each caplet)
    Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purposes
    Pain reliever/fever reducer
  • Uses
    • temporarily relieves minor aches and pains due to: • headache - • muscular aches - • minor pain of arthritis - • toothache - • backache - • the common cold - • menstrual cramps - • temporarily reduces ...
  • Warnings
    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives - • facial swelling - • asthma (wheezing) • shock - • skin ...
  • Directions
    • do not take more than directed • the smallest effective dose should be used - Adults and children 12 years and older: • take 1 caplet every 4 to 6 hours while symptoms persist - • if pain ...
  • Other information
    • read all warnings and directions before use • store between 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F) • see end panel for lot number and expiration ...
  • Inactive ingredients
    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid ...
  • Questions or comments?
    1-800-616-2471
  • Principal Display Panel
    MAJOR® SEE REVISED WARNING - Ibuprofen Tablets, 200mg - PAIN RELIEVER / FEVER REDUCER (NSAID) COMPARE TO the active ingredient of ADVIL® 50 COATED CAPLETS** ** Capsule-Shaped Tablets - Actual ...
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    Product Information