IBUPROFEN TABLET [AUROHEALTH LLC]

IBUPROFEN TABLET [AUROHEALTH LLC]
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NDC 58602-802-07, 58602-802-14, 58602-802-21, 58602-802-29, 58602-802-34, 58602-802-38
Set ID cf6fbf3b-a0f3-4e08-a981-d183fa285758
Category Human OTC Drug Label
Packager Aurohealth LLC
Generic Name
Product Class
Product Number
Application Number ANDA208865
  • 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 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

    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, 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 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 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 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
    • ask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. 
    • see top panel for lot number and expiration date
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

    Questions or comments?

    Call 1-855-274-4122
     

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648


    Code No.: TS/DRUGS/22/2009
    Made in India



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle)

    NDC 58602-802-21
    Ibuprofen Tablets USP
    200 mg
    Pain Reliever/Fever Reducer (NSAID)
    100 Coated Tablets
    AUROHEALTH
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablet Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)

    NDC 58602-802-21
    Ibuprofen Tablets USP
    200 mg
    Pain Reliever/Fever Reducer (NSAID)
    100 Coated Tablets
    AUROHEALTH
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton)

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (Light Orange to Orange) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code N;II
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-802-071 in 1 CARTON11/08/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-802-141 in 1 CARTON11/08/2017
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-802-211 in 1 CARTON11/08/2017
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-802-291 in 1 CARTON11/08/2017
    4150 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-802-34200 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2017
    6NDC:58602-802-38300 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20886511/08/2017
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-802) , MANUFACTURE(58602-802)

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