IBUPROFEN LIQUI-GELS (IBUPROFEN 200 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

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  • IBUPROFEN LIQUI-GELS (IBUPROFEN 200 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]

IBUPROFEN LIQUI-GELS (IBUPROFEN 200 MG) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]
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NDC 69168-363-07
Set ID bd0caf34-91ef-4dd4-9d03-a48385ffceea
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number ANDA079205
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  • Active ingredient

    Solubilized ibuprofen equal to 200mg 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 ■ 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 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, or kidney disease ■ you have asthma ■ you are taking a diuretic

    Ask a doctor or pharmacist before use if

    you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) 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 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

    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

    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
    ■ do not take longer than 10 days, unless directed by a doctor (see Warnings)
    Adults and children 12 years and older: ■ take 1 softgel every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 softgel, 2 softgels may be used ■ do not exceed 6 softgels in 24 hours unless directed by a doctor
    Children under 12 years: ask a doctor

  • Inactive Ingredients

    Ammonium hydroxide, FD&C green #3, gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol sorbitan, Sorbitan monooleate

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Ibuprofen 200 mg Softgel\LB1182 New.jpg
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  LIQUI-GELS
    ibuprofen 200 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-363-0710 in 1 CARTON; Type 0: Not a Combination Product12/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920512/22/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-363) , MANUFACTURE(69168-363) , LABEL(69168-363) , PACK(69168-363) , RELABEL(69168-363) , REPACK(69168-363)
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