IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]

IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]
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NDC 53329-677-30
Set ID 15821573-03c8-490f-9295-74430aa07dfe
Category HUMAN OTC DRUG LABEL
Packager Medline industries, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA076460
  • Active ingredient

    Ibuprofen USP, 200 mg (NSAID)*

    ----------------------------------------------------

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    minor pain of arthritis
    backache
    menstrual cramps
    muscular aches
    toothache
    the 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
    rash
    blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    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 thinning (anticoagulant) or steroid drug
    take other drugs containing prescription or nonprescription NSAIDs [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 DOCTOR

    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 high blood pressure, heart disease, liver cirrhosis, kidney disease
    you have asthma
    you are taking a diuretic

    Ask a doctor or pharmacist before use if

    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
    the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • STOP USE

    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
    pain gets worse or lasts more than 10 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present in the painful area
    any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    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 definitely 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

    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)

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed
    the smallest effective dose should be used
    adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
    if pain or fever does not respond to 1 tablet, 2 tablets may be used
    do not exceed 6 tablets in 24 hours, unless directed by a doctor
    children under 12 years: ask a doctor
  • Other Information

    store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive Ingredients  

    Carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide

  • Questions

    Questions or comments?

    Call Toll Free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm CST

  • Principal Display Panel

    Medline

    NDC 53329-677-30

    +Compare to the active ingredient in Advil Tablets

    Ibuprofen Tablets USP

    Pain Reliever/

    Fever Reducer (NSAID)

    200 mg

    100 coated tablets - 200 mg each

    Ibuprofen Tablets PDP and drug facts
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-677
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-677-301 in 1 CARTON
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07646004/21/2015
    Labeler - Medline industries, Inc. (025460908)