Label: IBUPROFEN tablet

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

Drug Label Information

Updated February 5, 2024

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  • Active ingredient (in each captet)
    Ibuprofen 200 mg (NSAID) *nonsteroidal anti-inflammatory drug
  • Purposes
    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
  • 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 ...
  • Stomach bleeding warning:
    This product contains an NSAID, which may cause severe stomach bleeding. The chances is higher if you: are age 60 or older - have had stomach ulcers or bleeding problems - take a blood thinning ...
  • Heart attack and stroke warning:
    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you - use more than directed or for longer than directed
  • Do not use
    if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer - right before or after heart surgery
  • 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 ...
  • Ask a doctor or pharmacist before use if you are
    taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin - under a doctor’s care for any serious condition - taking any other drug
  • When using this product
    take with food or milk if stomach upset occurs
  • 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 - you have symptoms of heart ...
  • If pregnant or breast-feeding,
    ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 and older - take 1 captet every 4 to 6 hours while symptoms persist • If pain or fever ...
  • Other Information
    store between 20 – 25°C (68 – 77°F). do not use if neck wrap or foil inner seal is broken or missing
  • Inactive ingredients
    colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium ...
  • Questions or comments?
    Call 1-877- 770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
  • Principal display panel
    225ct label
  • INGREDIENTS AND APPEARANCE
    Product Information