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Pill Identifier Information of Ibuprofen 200 MG Oral Tablet

Drug Information

Ibuprofen 200 MG Oral Tablet

Imprint: G;2
Shape: C48345
Color: C48326
Ingredients: Ibuprofen
Size: 14.00
Score: 1
Rxtty: SCD
Author: Granules India Limited
Inactive Ingredients: STARCH, CORN / POVIDONE K30 / STEARIC ACID / SILICON DIOXIDE / SODIUM STARCH GLYCOLATE TYPE A POTATO / HYPROMELLOSE 2208 (100 MPA.S) / TRIACETIN / LACTOSE MONOHYDRATE / TITANIUM DIOXIDE / FERRIC OXIDE RED / DEXTROSE MONOHYDRATE / LECITHIN, SOYBEAN / MALTODEXTRIN / CARBOXYMETHYLCELLULOSE SODIUM>

Complete Information

  • 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

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

  • WHEN USING THIS PRODUCT

  • 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
  • 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

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DIRECTIONS

  • SPL UNCLASSIFIED SECTION

    Other Information

    • store at 20-25°C (68-77°F)[See USP Controlled Room Temperature]
    • avoid high humidity and excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, 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

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Granules India Limited
    Hyderabad – 500 043, India
    MADE IN INDIA

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

    Distributed By:
    Granules USA, Inc.
    Parsippany, NJ 07054

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


    NDC# 62207-366-46

    See New Warnings Information


    ibu-366-250ct-carton.jpg

    IBUPROFEN TABLETS USP, 200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    Contains no ingredient made from a
    gluten-containing grain (wheat, barley, or rye)

    Do not use if foil inner seal is broken or missing.

    250 Coated Caplets †

    †Capsule-Shaped Tablets

    Important: Read all product information before using.

    Do not use if the foil inner seal is broken or missing

    NDC# 62207-366-47

    Do not use if the foil inner seal is broken or missing
    See New Warnings Information

    ibu-366-500ct-label.jpg

    IBUPROFEN TABLETS USP, 200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    Contains no ingredient made from a
    gluten-containing grain (wheat, barley, or rye)

    Do not use if foil inner seal is broken or missing.

    500 Coated Caplets†

    †Capsule-Shaped Tablets

    Important: Read all product information before using.


    NDC# 62207-396-46

    See New Warnings Information


    ibu-396-250ct-carton.jpgIBUPROFEN TABLETS USP, 200 mg


    Pain Reliever/Fever Reducer (NSAID)*

    Contains no ingredient made from a
    gluten-containing grain (wheat, barley, or rye)

    Do not use if foil inner seal is broken or missing.

    250 Coated Caplets†

    †Capsule-Shaped Tablets

    Important: Read all product information before using.



    NDC# 62207-396-46

    Do not use if the foil inner seal is broken or missing

    See New Warnings Information
    ibu-396-250ct-label.jpg

    IBUPROFEN TABLETS USP, 200 mg

    Pain Reliever/Fever Reducer (NSAID)*

    Contains no ingredient made from a
    gluten-containing grain (wheat, barley, or rye)

    Do not use if foil inner seal is broken or missing.

    500 Coated Caplets†

    †Capsule-Shaped Tablets

    Important: Read all product information before using.

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-365
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-365-5110 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    2NDC:62207-365-4124 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    3NDC:62207-365-4250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    4NDC:62207-365-43100 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    5NDC:62207-365-46250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    6NDC:62207-365-47500 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    7NDC:62207-365-48750 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    8NDC:62207-365-491000 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/01/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-366
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeOVAL ((Capsule shaped tablet)) Size14mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-366-5110 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    2NDC:62207-366-4124 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    3NDC:62207-366-4250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    4NDC:62207-366-43100 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    5NDC:62207-366-46250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    6NDC:62207-366-47500 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    7NDC:62207-366-48750 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    8NDC:62207-366-491000 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/01/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-396
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeOVAL ((Capsule shaped tablet)) Size14mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-396-5110 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    2NDC:62207-396-4124 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    3NDC:62207-396-4250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    4NDC:62207-396-43100 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    5NDC:62207-396-46250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    6NDC:62207-396-47500 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    7NDC:62207-396-48750 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    8NDC:62207-396-491000 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917408/13/2019
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-395
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-395-5110 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    2NDC:62207-395-4124 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    3NDC:62207-395-4250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    4NDC:62207-395-43100 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    5NDC:62207-395-46250 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    6NDC:62207-395-47500 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    7NDC:62207-395-48750 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    8NDC:62207-395-491000 in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917408/13/2019
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(62207-365, 62207-366, 62207-395, 62207-396)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRANULES LIFE SCIENCES PRIVATE LIMITED644776835analysis(62207-365, 62207-366, 62207-395, 62207-396) , manufacture(62207-365, 62207-366, 62207-395, 62207-396) , pack(62207-365, 62207-366, 62207-395, 62207-396) , label(62207-365, 62207-366, 62207-395, 62207-396)