IBUPROFEN (IBUPROFEN) TABLET [KINRAY]

IBUPROFEN (IBUPROFEN) TABLET [KINRAY]
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NDC 61715-059-56
Set ID d01782d0-5019-48a2-af66-0f0c03cf95e2
Category HUMAN OTC DRUG LABEL
Packager Kinray
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • Active ingredient (in each tablet)

    Ibuprofen USP 200 mg (NSAID)**
    **nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/ fever reducer

  • Uses

    • temporarily relieves minor aches and pain 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 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 everyday 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

    • the 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 or asthma
    • you are taking a diuretic
  • 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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
    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

    • store between 20o- 25oC (68o- 77oF)
    • see end panel for lot number and expiration date
  • Inactive Ingredients:

    colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • Questions or comments? 1-877-586-7979

  • PRINCIPAL DISPLAY PANEL - 200 mg TABLET CARTON

    Preferred Plus Pharmacy

    NDC 61715-059-56

    SEE NEW WARNINGS INFORMATION

    *Compare to the Active Ingredient in ADVIL®

    Ibuprofen TABLETS, USP 200 mg

     Pain Reliever/Fever Reducer (NSAID)

    200 COATED TABLETS

    Distributed By:

    Kinray, Inc., Whitestone, NY 11357

    (c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.image description

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-059
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-059-561 in 1 CARTON
    1200 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123907/25/2011
    Labeler - Kinray (012574513)
    Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Kentucky, LLC557054835repack(61715-059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975manufacture(61715-059)

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