Label: IBUPROFEN tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 30, 2019

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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 pain 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 ...
  • Do not use
    if you have ever had an allergic reaction to any other pain reliever/ fever reducer - right before or after heart surgery
  • Ask a doctor before use if
    stomach bleeding warning applies to you - you have problems or serious side effects from taking pain relievers or fever reducers - you have a history of stomach problems, such as heartburn - you have ...
  • Ask a doctor or pharmacist before use if you are
    under a doctor's care for any serious condition - taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin - taking any other drug
  • when using this product
    take with food or milk if stomach upset occurs - the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • stop use and ask a doctor if
    you experience any of the following signs of stomach bleeding: feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better - pain gets worse or lasts more than 10 ...
  • 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 definitely directed to do so by a doctor because it may cause ...
  • Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
  • Directions
    Do not take more than directed - The smallest effective dose should be used - adults and children 12 years of age and overTake 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever ...
  • Other information
    Tamper Evident: do not use if safety seal under cap is broken or missing - store at room temperature (20o- 25oC)  avoid excessive heat above 40oC (104oF)
  • Inactive ingredients
    carnuba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, stearic ...
  • Questions or comments?
    (866) 562-2756 Mon-Fri: 8 AM to 4 PM
  • HOW SUPPLIED
    Product: 50090-3977 - NDC: 50090-3977-0 50 TABLET, FILM COATED in a BOTTLE - NDC: 50090-3977-3 24 TABLET, FILM COATED in a BOTTLE - NDC: 50090-3977-5 30 TABLET, FILM COATED in a ...
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