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

IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC]
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NDC 59556-811-06, 59556-811-08, 59556-811-25, 59556-811-41, 59556-811-44, 59556-812-06, 59556-812-08, 59556-812-25, 59556-812-41, 59556-812-44
Set ID 798053dd-10f6-4c2e-8de8-1222dbd0d169
Category HUMAN OTC DRUG LABEL
Packager Strides Pharma Inc
Generic Name
Product Class
Product Number
Application Number ANDA206989
  • ACTIVE INGREDIENT(S)

    (in each white 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 YOU ARE

    • 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 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 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
    • Very low sodium
    • Each tablet contains 0.714 mg of Magnesium
  • 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?

    Call 1-855-742-7868

    Manufactured by:

    Strides Shasun Limited,

    Puducherry - 605 014, India

    PON/DRUGS/16134193

    Distributed by:

    Strides Pharma Inc

    East Brunswick, NJ 08816

    July 2017

  • PRINCIPAL DISPLAY PANEL

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

    NDC 59556-811-41

    Ibuprofen Tablets USP

    200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    24 Coated Tablets

    *nonsteroidal anti-inflammatory drug

    24 Coated round coated
    24 s round bottle

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

    NDC 59556-812-41

    Ibuprofen Tablets USP

    200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    24 Coated Caplets**

    **capsule-shaped tablets

    *nonsteroidal anti-inflammatory drug

    24s caplet carton
    24s caplet bottle
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-812
    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)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (CAPLET SHAPED) Size14mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-812-411 in 1 CARTON06/29/2018
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-812-251 in 1 CARTON06/29/2018
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-812-061 in 1 CARTON06/29/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-812-441 in 1 CARTON06/29/2018
    4165 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-812-081 in 1 CARTON06/29/2018
    51000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20698906/29/2018
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-811
    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)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (ROUND SHAPED) Size10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-811-411 in 1 CARTON06/29/2018
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-811-251 in 1 CARTON06/29/2018
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-811-061 in 1 CARTON06/29/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-811-441 in 1 CARTON06/29/2018
    4165 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-811-081 in 1 CARTON06/29/2018
    51000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20698906/29/2018
    Labeler - Strides Pharma Inc (078868278)
    Registrant - Strides Pharma Global Pte. Ltd. (659220961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited871402375ANALYSIS(59556-811, 59556-812) , MANUFACTURE(59556-811, 59556-812) , PACK(59556-811, 59556-812)

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