Label: IBUPROFEN tablet, film coated

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

Drug Label Information

Updated September 5, 2012

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  • Active ingredient (in each tablet)
    Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
  • Purpose
    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 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 ...
  • Ask a doctor before use if
    you have problems or serious side effects from taking pain relievers or fever reducers - the stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you ...
  • Directions
    do not take more than directed    the smallest effective dose should be used -  adults and children 12 years and older  -  take 1 tablet every 4 to 6 hours while symptoms persist  -  if pain or ...
  • 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) see end panel for lot number and expiration date {For Carton ...
  • 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?
    1-800-719-9260
  • Principal Display Panel
    Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 - SEE NEW WARNINGS INFORMATION - Ibuprofen Tablets, 200mg - PAIN RELIEVER / FEVER REDUCER (NSAID) COMPARE TO the active ingredient of ...
  • INGREDIENTS AND APPEARANCE
    Product Information