NUPRIN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES ARCOLAB LIMITED]

NUPRIN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES ARCOLAB LIMITED]
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NDC 64380-788-31
Set ID 78de585a-6b73-4151-93bd-d73fa74a9614
Category Human OTC Drug Label
Packager Strides Arcolab Limited
Generic Name
Product Class
Product Number
Application Number ANDA079129
  • ACTIVE INGREDIENT(S)

    (in each tablet)

    Ibuprofen USP 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USE(S)

    • 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
    • rash
    • blisters
    • shock
    • skin reddening
    • asthma (wheezing)

    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 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 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

    • 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • STOP USE AND ASK 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 3days
    • 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 (1-800-222-1222) right away.

  • 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 20 – 25°C (68-77°F)
    • tamper evident: do not use if imprinted safety seal under cap is broken or missing
    • see end panel for lot number and expiration date
  • INACTIVE INGREDIENT (S)

    colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

    QUESTIONS OR COMMENTS?
    Adverse drug event Call (877)-244-9825


    MADE IN INDIA

    Mfg.Lic.No. DRUGS/PY/05 13 1523

    NUPRIN® is a registered trademark of SVADS Holdings SA


    Manufactured for:

    Strides Pharma Inc,


    East Brunswick, NJ 08816
    www.nuprin.com
    December 2015

  • PRINCIPAL DISPLAY PANEL

    Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
    NDC 64380-788-31
    400 Coated Tablets
    N TMNuprin®
    IBUPROFEN TABLETS,USP
    200 mg
    Pain Reliever/Fever Reducer (NSAID)*
    *nonsteroidal anti-inflammatory drug.
    400s-label
    400s-carton

  • INGREDIENTS AND APPEARANCE
    NUPRIN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64380-788
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUND (ROUND SHAPED) Size10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64380-788-311 in 1 CARTON
    1400 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912912/16/2015
    Labeler - Strides Arcolab Limited (650738743)
    Registrant - Shasun Pharmaceuticals Limited (915786829)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shasun Pharmaceuticals Limited915786829MANUFACTURE(64380-788)

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