IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]

IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]
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NDC 10267-3846-2, 10267-3852-2, 10267-3909-2
Set ID 237bcb87-64a0-415b-bd53-e9d3b8bf33b6
Category HUMAN OTC DRUG LABEL
Packager Contract Pharmacal Corp.
Generic Name
Product Class
Product Number
Application Number ANDA071265
  • SPL UNCLASSIFIED SECTION

    Important: Read all product information before using.
    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Drug Facts

  • ACTIVE INGREDIENT (in each tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    Temporarily relieves minor aches and pains due to:

    • headache
    • muscular ache
    • 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for longer time than directed

    Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 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 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 a doctor if

    • you experience and 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 (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 of age and over:

    ■ 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 of age: ■ Ask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • store between 20˚ to 25˚C (68˚to 77˚F)
    • avoid excessive heat above 40˚C (104˚F)
  • INACTIVE INGREDIENTS

    (White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

    (Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.

    (Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.

  • QUESTIONS or COMMENTS?

    Call 1-800-231-4670: weekdays 9:00 AM to 5:00 PM EST

  • SPL UNCLASSIFIED SECTION

    **This product is not manufactured or distributed by McNeil, owner of the registered trademark Motrin®IB

    Manufactured by:

    Contract Pharmacal Corp.

    135 Adams Avenue

    Hauppauge, NY 11788 USA

    www.cpc.com

    XXXXX-10-18

    Barcode

    Peel here for more information

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    See New Warnings

    CONTRACT PHARMACAL CORP NDC 10267-3909-2

    **Compares to the active ingredient in Motrin ®IB


    GLUTEN FREE

    Ibuprofen Tablets, USP 200 mg

    Pain Reliever/Fever Reducer

    (NSAID)

    250 Coated Tablets

    DYE-FREE

    NOT ACTUAL SIZE

    Ibuprofen white label 3909

    See New Warnings


    CONTRACT PHARMACAL CORP NDC 10267-3846-2

    **Compares to the active ingredient in Motrin ®IB

    GLUTEN FREE

    Ibuprofen Tablets, USP 200 mg

    Pain Reliever/Fever Reducer

    (NSAID)

    250 Coated Tablets

    NOT ACTUAL SIZE

    Ibuprofen Orange label 3846

    See New Warnings


    CONTRACT PHARMACAL CORP NDC 10267-3852-2

    **Compares to the active ingredient in Motrin ®IB

    GLUTEN FREE

    Ibuprofen Tablets, USP 200 mg

    Pain Reliever/Fever Reducer

    (NSAID)

    250 Coated Tablets

    NOT ACTUAL SIZE

    Ibuprofen Brown label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3852
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUND (convex) Size6mm
    FlavorImprint Code C1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10267-3852-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07126501/15/2014
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3846
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUND (convex) Size6mm
    FlavorImprint Code C1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10267-3846-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07126501/15/2014
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3909
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (convex) Size6mm
    FlavorImprint Code C1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10267-3909-2250 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07126501/15/2014
    Labeler - Contract Pharmacal Corp. (057795122)
    Registrant - Contract Pharmacal Corp. (057795122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.057795122pack(10267-3852, 10267-3846, 10267-3909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.968334974manufacture(10267-3852, 10267-3846, 10267-3909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.968335112manufacture(10267-3852, 10267-3846, 10267-3909)

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