IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC.]

IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC.]
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NDC 59556-805-06, 59556-805-08, 59556-805-41, 59556-806-06, 59556-806-08, 59556-806-41
Set ID 8ad91d2f-8f49-444a-bc1b-07a4f9ef5aed
Category Human OTC Drug Label
Packager Strides Pharma Inc.
Generic Name
Product Class
Product Number
Application Number ANDA207052
  • ACTIVE INGREDIENT(S)

    (in each yellow tablet or caplet**)

    Ibuprofen USP 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    **capsule-shaped tablets                               

  • 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      
    • 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

    • taking aspirin for heart attack or stroke, because ibuprofen USP 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 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 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 ibuprofenduring 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 or caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
    • do not exceed 6 tablets or caplets 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)
    • do not use if imprinted text "SEALED for YOUR PROTECTION" on the safety seal under cap is broken or missing
    • see end panel for lot number and expiration date
    • Sodium free
    • Each tablet contains 0.714mg of Magnesium
  • INACTIVE INGREDIENT (S)

    colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

    QUESTIONS OR COMMENTS?
    Call 1-855-742-7868 (toll-free)

    MADE IN INDIA
    Mfg.Lic.NO. : PON/DRUGS/16 13 4193
    NUPRIN® is a registered trademark of Strides Pharma, Inc.


    Manufactured for:
    Strides Pharma Inc.
    East Brunswick, NJ 08816
    www.nuprin.com

    August  2017

  • PRINCIPAL DISPLAY PANEL

    Package Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Carton, 200 mg Tablets
    See New Warnings
    NDC 59556-805-06
    100 Coated Tablets


    Nuprin®

    Ibuprofen Tablets, USP 200 mg
    Pain Reliever/Fever Reducer (NSAID)*
    *nonsteroidal anti-inflammatory drug


    nuprin-100s-cart-lbl



    Package Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Label, 200 mg Tablets


     Do not use if imprinted safety seal
    under cap is broken or missing

    NDC 59556-805-06
    100 Coated Tablets


    Nuprin®

    Ibuprofen Tablets, USP 200 mg
    Pain Reliever/Fever Reducer (NSAID)*
    Important: Read all product information before
    using. Keep the box for important information

    *nonsteroidal anti-inflammatory drug


    nuprin-100s-containr-lbl
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-806
    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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeCAPSULE (CAPLET SHAPED) Size14mm
    FlavorImprint Code N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-806-411 in 1 CARTON08/26/2016
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-806-061 in 1 CARTON08/26/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-806-081 in 1 CARTON08/26/2016
    31000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20705208/26/2016
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-805
    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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUND (ROUND SHAPED) Size10mm
    FlavorImprint Code N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-805-411 in 1 CARTON08/26/2016
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-805-061 in 1 CARTON08/26/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-805-081 in 1 CARTON08/26/2016
    31000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20705208/26/2016
    Labeler - Strides Pharma Inc. (078868278)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Shasun Limited871402375MANUFACTURE(59556-805, 59556-806)

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