Label: IBUPROFEN- ibuprofen capsule capsule, liquid filled

  • NDC Code(s): 56062-560-11, 56062-560-78, 56062-560-83
  • Packager: PUBLIX SUPER MARKETS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2024

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  • Active ingredient (in each capsule)
    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *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 ...
  • 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
  • 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 problems or ...
  • 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.
  • Directions
    do not take more than directed - the smallest effective dose should be used - adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist - if pain or fever does ...
  • Other information
    each capsule contains: potassium 20 mg - read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from ...
  • Inactive ingredients
    FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol
  • Questions or comments?
    call toll free - 1-888-235-2466
  • SPL UNCLASSIFIED SECTION
    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION - DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING. †This product is not ...
  • 80's carton
    NDC 56062-560-78 - Ibuprofen - Capsules, 200 mg - • Pain reliever/fever - reducer - (NSAID) • Mini capsules - • Smaller capsule, same strength - ACTUAL SIZE - 80 Softgels** **Liquid–filled ...
  • INGREDIENTS AND APPEARANCE
    Product Information