Label: REDICARE IBUPROFEN- ibuprofen 200mg tablet, film coated

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

Drug Label Information

Updated July 2, 2021

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

  • Active Ingredient (in each tablet) Purpose

    Ibuprofen 200 mg (NSAID) .........................................................................................pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ menstrual cramps ■ common cold ■ 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 reddening ■ blisters. If an allergic reaction occurs, stop use and seek medical help right away.
    Stomach Bleeding Warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed.

    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 use if you have:

    ■ problems or serious side effects from taking pain relievers or fever reducers ■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ■ ulcers ■ bleeding problems ■ high blood pressure ■ heart disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ reached age 60 or older

    Ask a doctor or pharmacist before use if you are:

    ■ taking any other drug containing as NSAID (prescription or non-prescription) ■ taking a blood thinning (anti-coagulated) or steroid drug ■ 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 ■ long term continuous use may increase the risk of heart attack or stroke.

    Stop use and ask a doctor if:

    ■ you feel faint, vomit blood or have bloody or black stools. These are signs of stomach bleeding ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ stomach pain or upset gets worse or lasts ■ redness or swelling is present in the painful area ■ any new symptoms appear

    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 specially directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years and older do not take more than directed - the smallest effective dose should be used - take 1 tablet every 4 to 6 hours while symptoms persist - If pain or fever does not respond to 1 tablet take a 2nd tablet - do not exceed 6 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age do not use unless directed by a doctor

  • Other Information:

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

  • Inactive Ingredients:

    Colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelantinized starch, talc, titanium dioxide.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    REDICARE IBUPROFEN 
    ibuprofen 200mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-750
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200   in 200 
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code IBU;200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-750-681 in 1 BOX; Type 0: Not a Combination Product02/01/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912902/01/2017
    Labeler - Redicare LLC (800149346)