Label: IBUPROFEN- ibuprofen 200mg tablet, film coated

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

Drug Label Information

Updated March 27, 2019

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  • ACTIVE INGREDIENT
    ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID) *nonsteroidal anti-inflammatory drug
  • PURPOSE
    pain reliever/fever reducer
  • INDICATIONS & USAGE
    Uses: temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces ...
  • WARNINGS
    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 ...
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by ...
  • KEEP OUT OF REACH OF CHILDREN
    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION
    Directions: Adults and children 12 years of age and older: • do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 6 hours while ...
  • INACTIVE INGREDIENT
    Inactive Ingredients: croscarmellose sodium*, FD& C Blue #2*, FD& C Red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium ...
  • PRINCIPAL DISPLAY PANEL
    ADVANCED IBUPROFEN
  • INGREDIENTS AND APPEARANCE
    Product Information