Label: DG HEALTH IBUPROFEN- ibuprofen tablet, film coated

  • NDC Code(s): 55910-604-62, 55910-604-71, 55910-604-76, 55910-604-78, view more
    55910-604-82, 55910-604-85, 55910-604-90, 55910-604-93
  • Packager: Dolgencorp, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 13, 2024

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  • Active ingredient (in each tablet)

    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 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

    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 heartburn
    •
    you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    •
    you are taking a diuretic

    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 problems or stroke:
    •
    chest pain
    •
    trouble breathing
    •
    weakness in one part or side of body
    •
    slurred speech
    •
    leg swelling
    •
    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

    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 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 (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 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

    •
    read all warnings and directions before use
    •
    store between 20-25°C (68-77°F)
    •
    avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

  • Questions or comments?

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    DG™|health

    Compare to the active ingredient of Advil® Ibuprofen Tablets

    Ibuprofen Tablets, 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    200 mg

    1000 Tablets

    Actual Tablet Size

    ibuprofen-image
  • INGREDIENTS AND APPEARANCE
    DG HEALTH IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-604
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code I2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-604-711 in 1 CARTON12/19/2009
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55910-604-781 in 1 CARTON11/28/2009
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55910-604-85250 in 1 BOTTLE; Type 0: Not a Combination Product10/03/2009
    4NDC:55910-604-90500 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2010
    5NDC:55910-604-621 in 1 CARTON04/28/201101/09/2014
    524 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55910-604-761 in 1 CARTON05/09/201210/18/2018
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55910-604-822 in 1 CARTON08/25/2016
    7100 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55910-604-931000 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07209610/03/2009
    Labeler - Dolgencorp, LLC (068331990)
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