Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated April 14, 2025

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  • Active ingredient(s)
    Ibuprofen USP, 200mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purpose
    Pain reliever/fever reducer
  • Use(s)
    temporarily relieves minor aches and pains due to: headache - toothache - backache - menstrual cramps - the common cold - muscular aches n minor pain of arthritis - temporarily reduces fever
  • 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 reddening rash ...
  • 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 or fever ...
  • Other information
    store between 20-25 °C (68-77° F) read all warnings and directions before use - do not use if seal under bottle cap is broken or missing
  • Inactive ingredients
    Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10, FD&C Blue #2, FD&C Yellow #6, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol ...
  • Questions/Comments
    Call 1-888-952-0050 - (Monday-Friday 9 AM – 5 PM EST)
  • Principal Display Panel
    Ibuprofen
  • INGREDIENTS AND APPEARANCE
    Product Information