Label: IBUPROFEN tablet

  • NDC Code(s): 72476-366-05, 72476-366-10
  • Packager: Retail Business Services, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)
    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 ...
  • 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 ...
  • 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 blood ...
  • 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 ...
  • 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 caplet every 4 to 6 hours ...
  • Other information
    ■ store between 20-25°C (68-77°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 Mon-Fri 8:00 AM EST to 5:00 PM PST
  • PDP
    Ibu Brown cap ...
  • INGREDIENTS AND APPEARANCE
    Product Information