Label: IBUPROFEN tablet, coated

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

Drug Label Information

Updated November 23, 2022

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient (in each tablet)
    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 over:     ■ take 1 tablet every 4 to 6 hours while ...
  • Other information
    read all warnings and directions before use - store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) retain carton for complete product information and ...
  • Inactive ingredients
    colloidal silicon dioxide, corn starch, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
  • PRINCIPAL DISPLAY PANEL
    TopCare® Health - COMPARE TO MOTRIN® IB ACTIVE INGREDIENT† NDC 36800-286-03 - Ibuprofen - Tablets,  200 mg - PAIN RELIEVER • FEVER REDUCER (NSAID) 100 COATED TABLETS - actual size
  • INGREDIENTS AND APPEARANCE
    Product Information