Label: IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated

  • NDC Code(s): 59556-857-42, 59556-858-42
  • Packager: Strides Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 13, 2023

If you are a consumer or patient please visit this version.

  • BOXED WARNING (What is this?)

    Important: Read all product information before using.

    Keep the box for important information.

  • ACTIVE INGREDIENT

     Active ingredient (in each Brown tablet or caplet**)

    Ibuprofen 200 mg (NSAID)*

    * nonsteroidal anti-inflammatory drug

    **capsule-shaped tablets

  • PURPOSE

    Purpose

    Pain reliever / fever reducer

  • Uses

    • 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 DOCTOR/PHARMACIST

    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
  • SPL UNCLASSIFIED SECTION

    Ask a doctor or pharmacist before use if you are

    • 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

    When using this product

    • take with food or milk if stomach upset occurs
  • STOP USE

    Stop use and ask a 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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

    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)

  • SPL UNCLASSIFIED SECTION

    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
  • STORAGE AND HANDLING

    Other Information

    • store between 20-250C (68-770F)
    • do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
  • Inactive Ingredients

    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)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Strides Pharma Science Limited,

    Puducherry - 605 014, India.

    Distributed by:

    Strides Pharma Inc.

    East Brunswick, NJ 08816

    January 2022

  • DOSAGE & ADMINISTRATION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    label
    label
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-857
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUND (Round shaped) Size10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-857-4210000 in 1 BAG; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912903/18/2022
    IBUPROFEN  IMMEDIATE RELEASE
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-858
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULE (capsule shaped) Size14mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-858-4210000 in 1 BAG; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912903/18/2022
    Labeler - Strides Pharma Inc (078868278)
    Registrant - Strides Pharma Global Pte. Ltd. (659220961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited871402375ANALYSIS(59556-857, 59556-858) , MANUFACTURE(59556-857, 59556-858) , PACK(59556-857, 59556-858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivimed Life Sciences Private Limited860477684ANALYSIS(59556-857, 59556-858) , MANUFACTURE(59556-857, 59556-858) , PACK(59556-857, 59556-858)