IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC]

IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC]
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NDC 12634-518-01, 12634-518-10, 12634-518-74
Set ID 3fd625e4-0d06-4efb-abd1-42281e7a6af0
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Apotheca, Inc
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • ACTIVE INGREDIENT

    Ibuprofen 200 mg (NSAID)*

    * nonstreoidal anti-inflammatory drug

  • PURPOSE

    Pain reliever / fever reducer


    Use(s)

    temporarily relieves minor aches and pain due to :
    backache
    headache
    menstrual cramps
    minor pain of arthritis
    muscular aches
    the common cold
    toothache
    temporarily reduces fever

  • WARNINGS

    Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin. 
    Symptoms may include: 

    • asthma (wheezing)
    • blisters
    • facial swelling
    • hives
    • rash
    • shock
    • skin reddening


    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 stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have bad stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • the 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/PHARMACIST

    Ask a doctor before 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 or kidney disease
    • taken a diuretics
    • reached age 60 or older


    Ask a doctor or pharmacist before use if you are

    • taking any other drugs containg an NSAID (prescription or nonprescription)
    • taking a blood thining (anticoagulant) or steriod drug
    • under a doctor’s care for any serious condition
    • taking aspirin for heart attacks 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
    • long term continuous use may increase the risk of heart attack or stroke


    Stop use and ask 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 painful area
    • any new symptoms appear
  • PREGNACNCY 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 a 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 PoisonControlCenter right away. (1-800-222-1222)

  • INACTIVE INGREDIENTS

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

  • QUESTIONS

    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 docter 

    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 20-25 0c (68-77 0 F).

    • do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing
  • PRINCIPAL DISPLAY PANEL

    Manufactured for:
    Marksans Pharma Inc.
    Lake Grove, NY11755, USA

    Manufactured by:
    Marksans Pharma Ltd.
    Verna, Goa-403722, India

    Repackaged and Distributed by:
    Apotheca, Inc.
    Phoenix, AZ 85006

    Repackaged and Distributed for:

    RejuviLife

    Phoenix, AZ 85015

    NDC 12634-518-74

    IBUPROFEN

    MAXIMUM STRENGTH

    WITHOUT A PRESCRIPTION 

    BROWN COATED TABLETS

    Pain Reliver

    Fever Reducer

    RejuviLife®

    24 TABLETS 200MG

    LABEL

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12634-518(NDC:25000-114)
    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)  
    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:12634-518-7424 in 1 BOTTLE
    2NDC:12634-518-01100 in 1 BOTTLE
    3NDC:12634-518-101000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123902/14/2014
    Labeler - Apotheca, Inc (051457844)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca, Inc051457844repack(12634-518)

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