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

IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC.]
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NDC 59556-855-06, 59556-855-07, 59556-855-08, 59556-855-25, 59556-855-41, 59556-855-44, 59556-855-46, 59556-856-06, 59556-856-07, 59556-856-08, 59556-856-25, 59556-856-41, 59556-856-44, 59556-856-46
Set ID 1f4159ad-d58c-4519-932b-030cc2735514
Category Human OTC Drug Label
Packager Strides Pharma Inc.
Generic Name
Product Class
Product Number
Application Number ANDA091355
  • ACTIVE INGREDIENT(S)

    (ineach orange 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 USP 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 non prescription 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 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 ad 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
    • 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
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble in 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 3 days      
    • redness or swelling is present in the painful area
    • any new symptoms appear               

      If pregnant or breast-feeding, ask a health care professional before use. it is especially important not to use ibuprofen USP
     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 centre (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 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
    • Sodium free 
    • Each tablet contains 0.714 mg of Magnesium
    • see end panel for lot number and expiration date.


  • INACTIVE INGREDIENTS (S)


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

    QUESTIONS OR COMMENTS?
    Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST

    Manufactured by:
    Strides Shasun Limited,
    Puducherry - 605 014, India.
    PON/DRUGS/16134193

    Distributed by:
    Strides Pharma Inc.
    East Brunswick, NJ 08816


    May 2017



  • PRINCIPAL DISPLAY PANEL


    Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

    See New Warnings

    NDC 59556-856-41

    Ibuprofen Tablets, USP

    200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    24 Coated Caplets**

    **capsule-shaped tablets

    *nonsteroidal anti-inflammatory drug

    ibu-24-cap-car

     


    ibu-24-cap-cont



    Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets


    See New Warnings

    NDC 59556-855-41

    Ibuprofen Tablets, USP

    200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    24 Coated Tablets

    *nonsteroidal anti-inflammatory drug

    ibu-24-tab-car




    ibu-24-tab-cont






  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-856
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULE (CAPLET SHAPED) Size14mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-856-411 in 1 CARTON04/04/2011
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-856-251 in 1 CARTON04/04/2011
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-856-061 in 1 CARTON04/04/2011
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-856-441 in 1 CARTON04/04/2011
    4165 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-856-071 in 1 CARTON04/04/2011
    5500 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:59556-856-081 in 1 CARTON04/04/2011
    61000 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:59556-856-461000 in 1 BAG; Type 0: Not a Combination Product04/04/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135504/04/2011
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-855
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (ROUND SHAPED) Size10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-855-411 in 1 CARTON04/04/2011
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-855-251 in 1 CARTON04/04/2011
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-855-061 in 1 CARTON04/04/2011
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-855-441 in 1 CARTON04/04/2011
    4165 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-855-071 in 1 CARTON04/04/2011
    5500 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:59556-855-081 in 1 CARTON04/04/2011
    61000 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:59556-855-461000 in 1 BAG; Type 0: Not a Combination Product04/04/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135504/04/2011
    Labeler - Strides Pharma Inc. (078868278)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Shasun Limited871402375ANALYSIS(59556-855, 59556-856) , MANUFACTURE(59556-855, 59556-856)

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