Label: IBUPROFEN MINIS- ibuprofen capsule, liquid filled

  • NDC Code(s): 58602-858-12, 58602-858-18, 58602-858-23, 58602-858-30, view more
    58602-858-34, 58602-858-42, 58602-858-70, 58602-858-72, 58602-858-73, 58602-858-80, 58602-858-96, 58602-858-98
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 15, 2023

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
      • the common cold
      • muscular aches
      • 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 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 (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 15 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

    FD & C Green No. 3, gelatin, polyethylene glycol, potassium hydroxide, purified water and sorbitol sorbitan solution.


    Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


    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 - Container Label 200 mg (80 Liquid Filled Capsules)

    AUROHEALTH

    NDC 58602-858-18


    Ibuprofen Capsules
    200 mg
    (minis)

    Pain Reliever/Fever Reducer (NSAID)

                                                                   80
                                Liquid Filled Capsules 

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label 200 mg (80 Liquid Filled Capsules)
                              


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label 200 mg (80 Liquid Filled Capsules)

    AUROHEALTH

    NDC 58602-858-18


    †Compare to the active Ingredient
    of Advil LIQUI®-GELS®

    Ibuprofen Capsules 200 mg
    (minis)

    Pain Reliever/Fever Reducer (NSAID)

     Smaller Capsule                                         80

     Same Strength                         Liquid Filled 
                                                              Capsules

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – Container Carton Label 200 mg (80 Liquid Filled Capsules)

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN MINIS 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-858
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorGREEN (transparent) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code Q21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-858-731 in 1 CARTON09/14/2023
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-858-121 in 1 CARTON09/14/2023
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-858-181 in 1 CARTON09/14/2023
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-858-231 in 1 CARTON09/14/2023
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-858-30160 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2023
    6NDC:58602-858-34200 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2023
    7NDC:58602-858-42240 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2023
    8NDC:58602-858-961 in 1 CARTON09/14/2023
    820 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:58602-858-701 in 1 CARTON09/14/2023
    940 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:58602-858-721 in 1 CARTON09/14/2023
    1080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    11NDC:58602-858-80200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/2023
    12NDC:58602-858-98240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21577709/14/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-858) , MANUFACTURE(58602-858)