Label: IBUPROFEN tablet

  • NDC Code(s): 58602-713-01, 58602-713-02, 58602-713-03, 58602-713-05, view more
    58602-713-06, 58602-713-07, 58602-713-08, 58602-713-09, 58602-713-10, 58602-713-15, 58602-713-34, 58602-713-36, 58602-713-40, 58602-713-41, 58602-713-45, 58602-713-48, 58602-713-49, 58602-713-52, 58602-713-53, 58602-713-56, 58602-713-57, 58602-713-58, 58602-713-59, 58602-713-63, 58602-713-71, 58602-713-73, 58602-713-75, 58602-713-83, 58602-713-86, 58602-713-87
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 23, 2022

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

  • Drug Facts

    Active ingredient (in each caplet)

    Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

  • Purposes

    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 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

    • 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
  • 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 bottom panel for lot number and expiration date
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide and yellow iron oxide

    Questions or comments?

    Call 1-855-274-4122

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/16/2014


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

    AUROHEALTH
    NDC 58602-713-07
    Ibuprofen Tablets USP
    200 mg
    Pain Reliever/Fever Reducer (NSAID)
    100 Coated Caplets*                   *Capsule-Shaped Tablets

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




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

    AUROHEALTH
    NDC 58602-713-07
    #Compare to the active
    ingredient of MOTRIN® IB
    Ibuprofen Tablets USP
    200 mg
    Pain Reliever/Fever Reducer (NSAID)
    100 Coated Caplets*                 *Capsule-Shaped Tablets

    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:58602-713
    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)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorBROWN (Light Brown to Brown) Scoreno score
    ShapeCAPSULE (Biconvex) Size15mm
    FlavorImprint Code N;I
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-713-731 in 1 CARTON03/22/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-713-571 in 1 CARTON03/22/2022
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-713-091 in 1 CARTON03/22/2022
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-713-101 in 1 CARTON03/22/2022
    460 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-713-561 in 1 CARTON03/22/2022
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-713-071 in 1 CARTON03/22/2022
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-713-531 in 1 CARTON03/22/2022
    7150 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-713-831 in 1 CARTON03/22/2022
    8200 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:58602-713-59225 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    10NDC:58602-713-71250 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    11NDC:58602-713-49300 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    12NDC:58602-713-48500 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    13NDC:58602-713-63550 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    14NDC:58602-713-86750 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    15NDC:58602-713-581000 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    16NDC:58602-713-451500 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2022
    17NDC:58602-713-011 in 1 CARTON03/22/2022
    1724 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    18NDC:58602-713-051 in 1 CARTON03/22/2022
    1840 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    19NDC:58602-713-081 in 1 CARTON03/22/2022
    1950 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    20NDC:58602-713-151 in 1 CARTON03/22/2022
    2060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    21NDC:58602-713-061 in 1 CARTON03/22/2022
    2190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    22NDC:58602-713-021 in 1 CARTON03/22/2022
    22100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    23NDC:58602-713-031 in 1 CARTON03/22/2022
    23150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    24NDC:58602-713-34200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    25NDC:58602-713-36250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    26NDC:58602-713-75300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    27NDC:58602-713-40500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    28NDC:58602-713-87550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    29NDC:58602-713-52700 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    30NDC:58602-713-411000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20886503/22/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-713) , MANUFACTURE(58602-713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-713) , MANUFACTURE(58602-713)