Label: PAIN RELIEVER / FEVER REDUCER- ibuprofen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 17, 2021

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  • Active Ingredient
    Ibuprofen 200 mg (NSAID)1 - 1 - nonsteroidal anti-inflammatory drug
  • Purpose
    Pain reliever/Fever reducer
  • Uses:
    temporarily relieves minor aches and pains due to: headache - toothache - backache - menstrual cramps - the common cold - muscular aches - 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 ...
  • 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 symptoms persist - if pain or fever does ...
  • OTHER INFORMATION
    each tablet contains: sodium 22mg - read all product information before use. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS
    Pregelatinized Starch, Maize Starch, Sodium Starch Glycolate, Povidone K-30, Purified Water, Stearic Acid, Colloidal Silicon Dioxide, Opadry II 85F565026
  • QUESTIONS OR COMMENTS?
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  • 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.
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