Label: IBUPROFEN tablet

  • NDC Code(s): 62207-365-16, 62207-365-24, 62207-365-25, 62207-365-26, view more
    62207-365-27, 62207-365-66, 62207-365-67, 62207-365-68, 62207-365-80, 62207-366-24, 62207-366-25, 62207-366-26, 62207-366-27, 62207-366-66, 62207-366-67, 62207-366-68, 62207-366-80
  • Packager: Granules India Limited
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated December 14, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Ibuprofen 200 mg (NSAID)*

  • PURPOSE

    Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug

  • 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 id 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 a caplet every 4 to 6 hours while symptoms persist
    ■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used
    ■ do not exceed 6 tablets in 24 hours , unless directed by a doctor
    childer under 12 years■ ask a doctor
  • SPL UNCLASSIFIED SECTION

    OTHER INFORMATION

    ■ store between 20-25ºC (68-77ºF)

    ■ do not use if foil inner seal is broken or missing

    ■ see end panel for lot number and expiration date

  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maize starch, maltodextrin, pregelatinized starch, povidone k30, sodium starch glycolate, stearicacid, sodium carboxymellose, triacetin, titanium dioxide

  • QUESTIONS OR COMMENTS?

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

  • SPL UNCLASSIFIED SECTION

    M.L. 37/RR/AR/2003/F/R
    Manufactured By:
    Granules India Limited
    2nd Floor 3rd Black, My Home hub
    Madhapur, Hyderabad – 500 081, India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    ibu-200mg-round-80kg.jpgibu-roundibu-caplet

    365-68365-68-shipper366-68366-68-shipper

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-365
    Route of AdministrationNOT APPLICABLE
    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)  
    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
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-365-2448000 in 1 BOX01/01/2011
    2NDC:62207-365-2571000 in 1 BOX01/01/2011
    3NDC:62207-365-2680000 in 1 BOX01/01/2011
    4NDC:62207-365-2797000 in 1 BOX01/01/2011
    5NDC:62207-365-66258000 in 1 DRUM01/01/2011
    6NDC:62207-365-67190476 in 1 DRUM01/01/2011
    7NDC:62207-365-80258000 in 1 DRUM01/01/2011
    8NDC:62207-365-68175000 in 1 BOX01/01/2011
    9NDC:62207-365-16258899 in 1 DRUM11/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2011
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-366
    Route of AdministrationNOT APPLICABLE
    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)  
    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
    ColorredScoreno score
    ShapeOVAL (caplet) Size14mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-366-2448000 in 1 BOX01/01/2011
    2NDC:62207-366-2571000 in 1 BOX01/01/2011
    3NDC:62207-366-2680000 in 1 BOX01/01/2011
    4NDC:62207-366-2797000 in 1 BOX01/01/2011
    5NDC:62207-366-66258000 in 1 DRUM01/01/2011
    6NDC:62207-366-67190476 in 1 DRUM01/01/2011
    7NDC:62207-366-80258000 in 1 DRUM01/01/2011
    8NDC:62207-366-68175000 in 1 BOX01/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/2011
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(62207-365, 62207-366)