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Ibuprofen (Granules India Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1000 TABLET in 1 BOTTLE (62207-365-49) Label Information
TABLET 24 TABLET in 1 BOTTLE (62207-365-41) Label Information
TABLET 250 TABLET in 1 BOTTLE (62207-365-46) Label Information
TABLET 100 TABLET in 1 BOTTLE (62207-365-43) Label Information
TABLET 750 TABLET in 1 BOTTLE (62207-365-48) Label Information
TABLET 10 TABLET in 1 BOTTLE (62207-365-51) Label Information
TABLET 500 TABLET in 1 BOTTLE (62207-365-47) Label Information
TABLET 50 TABLET in 1 BOTTLE (62207-365-42) Label Information

Complete Ibuprofen Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT (in each tablet/caplet)

    Ibuprofen 200 mg (NSAID) *

    * nonsteroidal anti-inflammatory drug

  • 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
  • DO NOT USE

    • if you have ever had an allergic reaction to 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
    • you have asthma
    • 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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
      • 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 caplet every 4 to 6 hours while symptoms persist
      • if pain or fever does not respond to 1 caplet, 2 caplets may be used
      • do not exceed 6 caplets in 24 hours, unless directed by a doctor
      Children under 12 years
      • ask a doctor
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store at 20° – 25°C (68 – 77°F). [See USP Controlled Room Temperature]
    • Avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

  • QUESTIONS OR COMMENTS?

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

  • SPL UNCLASSIFIED SECTION

    MADE IN INDIA

    M.L.No: 37/RR/AP/2003/F/R

    Manufactured By
    Granules India Limited
    2nd Floor 3rd Block, My Home hub, Madhapur, Hyderabad – 500 081, INDIA

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Do not use if the foil inner seal is broken or missing
    NDC# 62207-365-43
    See New Warnings Information

    IBUPROFEN TABLETS USP, 200 mg
    Pain Reliever/Fever Reducer (NSAID)

    100 Tablets**

    Important: Read all product information before using.

    cbb96637-figure-01

    Do not use if the foil inner seal is broken or missing
    NDC# 62207-366-43
    See New Warnings Information

    IBUPROFEN TABLETS USP, 200 mg
    Pain Reliever/Fever Reducer (NSAID)

    100 Coated Caplets**
    **Capsule-Shaped Tablets

    Important: Read all product information before using.

    cbb96637-figure-02
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-365
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    TRIACETIN (UNII: XHX3C3X673)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code G;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62207-365-51 10 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:62207-365-41 24 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:62207-365-42 50 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:62207-365-43 100 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:62207-365-46 250 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:62207-365-47 500 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:62207-365-48 750 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:62207-365-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079174 01/01/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-366
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    TRIACETIN (UNII: XHX3C3X673)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL (caplet) Size 14mm
    Flavor Imprint Code G;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62207-366-51 10 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:62207-366-41 24 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:62207-366-42 50 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:62207-366-43 100 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:62207-366-46 250 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:62207-366-47 500 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:62207-366-48 750 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:62207-366-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079174 01/01/2011
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    Name Address ID/FEI Business Operations
    Granules India Limited 918609236 MANUFACTURE(62207-365, 62207-366)
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