Label: IBUPROFEN capsule

  • NDC Code(s): 58602-902-12, 58602-902-18, 58602-902-30, 58602-902-38, view more
    58602-902-73
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 24, 2019

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

  • Drug Facts

    Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
    (present as the free acid and potassium salt)
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/Fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • toothache 
      • backache
      • menstrual cramps
      • muscular aches
      • the common cold
      • minor pain of arthritis 
    • 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 any other pain reliever/fever reducer
    • right before or after heart surgery
  • Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • 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

    • under a doctor’s care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • 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 (1-800-222-1222) right away.

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    black iron oxide, FD & C green no. 3,  gelatin,  hypromellose, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution

    Questions or comments?

    call 1-855-274-4122

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

    Made in India   

    Code No.: TS/DRUGS/22/2009 

    Issued: August 2017

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Bottle)

    NDC 58602-902-12
    Ibuprofen Capsules
    200 mg
    Pain Reliever/Fever Reducer (NSAID)
    40 Liquid Filled Capsules

    READ ANDA KEEP CARTON FOR COMPLETE
    WARNING AND INFORMATION
    AUROHEALTH
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsule Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Container Carton)

    NDC 58602-902-12
    Ibuprofen Capsules 200 mg
    Pain Reliever/Fever Reducer (NSAID)
    40 Liquid Filled Capsules
    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
    AUROHEALTH

    ibuprofen-fig2

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeRECTANGLE (Oblong) Size19mm
    FlavorImprint Code I200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-902-731 in 1 CARTON06/29/2018
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-902-121 in 1 CARTON06/29/2018
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-902-181 in 1 CARTON06/29/2018
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-902-30160 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
    5NDC:58602-902-38300 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20775306/29/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-902) , MANUFACTURE(58602-902)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-902) , MANUFACTURE(58602-902)