Label: IBUPROFEN tablet

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

Drug Label Information

Updated December 10, 2024

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  • Active ingredient (in each caplet)
    Ibuprofen 200 mg (NSAID)*
  • 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 ...
  • 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 ■ rash ...
  • Stomach bleeding warning:
    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older - ■ have had stomach ulcers or bleeding problems - ■ take a ...
  • 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 ...
  • 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 ...
  • 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 caplet every 4 to 6 hours while symptoms persist - ■ if pain ...
  • Other information
    ■ store between 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature] ■ avoid excessive heat above 40°C (104°F)
  • Inactive ingredients
    colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
  • Questions or comments?
    call - 1-877-770-3183 weekdays 8:00 AM EST to 5:00 PM PST
  • PDP
    Ibu Brown
  • INGREDIENTS AND APPEARANCE
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