IBUPROFEN TABLET [GRANULES INDIA LIMITED]

IBUPROFEN TABLET [GRANULES INDIA LIMITED]
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NDC 62207-357-41, 62207-357-42, 62207-357-43, 62207-357-46, 62207-357-47, 62207-357-48, 62207-357-49, 62207-357-91, 62207-358-41, 62207-358-42, 62207-358-43, 62207-358-46, 62207-358-47, 62207-358-48, 62207-358-49, 62207-358-91
Set ID b36c24b3-7bba-4698-a71c-ca617ea1060e
Category HUMAN OTC DRUG LABEL
Packager Granules India Limited
Generic Name
Product Class
Product Number
Application Number ANDA202312
  • ACTIVE INGREDIENT(S)

    Ibuprofen 200mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • 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 stomach

    bleeding. The chances 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, or 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 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 than10 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/caplet every 4 to 6 hours  while symptoms persist.
    • if pain or fever does not respond to 1 tablet/caplet, 2 tablets/caplets may be
      used.
    • do not exceed 6 tablets/caplets in 24 hours, unless directed by a doctor.
    children under 12 years
    • ask a doctor
  • OTHER INFORMATION

    • store between 20° to 25°C (68° to 77°F).
    • do not use if neck wrap or foil inner seal is broken or missing

  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol

    povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • QUESTIONS OR COMMENTS?

    Call 1-877- 770-3183
    weekdays 9:00 AM to 4:30 PM EST

  • PRINCIPAL DISPLAY PANEL

    ibu-orange-tab-50-jpgibu-orange-tab-1000-jpgibu-orange-cap-bulk-jpgibu-orange-cap-1000-jpgibu-orange-cap-50-jpg

    ibu-orange-tab-bulk-jpg

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-357
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-357-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    2NDC:62207-357-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    3NDC:62207-357-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    4NDC:62207-357-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    5NDC:62207-357-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    6NDC:62207-357-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    7NDC:62207-357-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    8NDC:62207-357-91160000 in 1 DRUM10/08/2018
    81 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20231211/17/2016
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-358
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code G;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-358-4124 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    2NDC:62207-358-4250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    3NDC:62207-358-43100 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    4NDC:62207-358-46250 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    5NDC:62207-358-47500 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    6NDC:62207-358-48750 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    7NDC:62207-358-491000 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2016
    8NDC:62207-358-91160000 in 1 DRUM11/17/2016
    81 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20231211/17/2016
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236manufacture(62207-357, 62207-358) , label(62207-357, 62207-358)

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