Label: CHILDRENS IBUPROFEN - ibuprofen suspension

  • NDC Code(s): 58602-200-20, 58602-200-24
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 19, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

    Active ingredient (in each 5 mL)


    Ibuprofen USP 100 mg (NSAID)*

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  • Purpose

    Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

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  • Uses

    temporarily:

    • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    • reduces fever
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  • 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 your child:


    • has had stomach ulcers or bleeding problems
    • takes a blood thinning (anticoagulant) or steroid drug
    • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • takes 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.

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

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  • Do not use

    • if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    • right before or after heart surgery
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  • Ask a doctor before use if

    • stomach bleeding warning applies to your child
    • child has a history of stomach problems, such as heartburn
    • child has problems or serious side effects from taking pain relievers or fever reducers
    • child has not been drinking fluids
    • child has lost a lot of fluid due to vomiting or diarrhea
    • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
    • child has asthma
    • child is taking a diuretic
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  • Ask a doctor or pharmacist before use if the child is

    • under a doctor's care for any serious condition
    • taking any other drug
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  • When using this product

    • take with food or milk if stomach upset occurs
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  • Stop use and ask a doctor if

    • child experiences any of the following signs of stomach bleeding:
      • feels faint
      • vomits blood
      • has bloody or black stools
      • has stomach pain that does not get better
    • child has symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • weakness in one part or side of body
      • slurred speech
      • leg swelling
    • the child does not get any relief within first day (24 hours) of treatment
    • fever or pain gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear
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  • 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)

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  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • shake well before using
    • mL = milliliter
    • find right dose on chart. If possible, use weight to dose; otherwise use age.
    • use only enclosed dosing cup. Do not use any other dosing device.
    • if needed, repeat dose every 6 to 8 hours
    • do not use more than 4 times a day
    • replace original bottle cap to maintain child resistance
    • wash dosage cup after each use

    Dosing Chart
    * or as directed by a doctor
    Weight (lb)
    Age (year)
    Dose (mL)*
    under 24
    under 2 years
    ask a doctor
    24-35 lbs
    2-3 years
    5 mL
    36-47 lbs
    4-5 years
    7.5 mL
    48-59 lbs
    6-8 years
    10 mL
    60-71 lbs
    9-10 years
    12.5 mL
    72-95 lbs
    11 years
    15 mL
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  • Other information

    • each 5 mL contains: sodium 2 mg
    • store between 20 to 25°C (68 to 77°F)
    • do not use if carton is opened or seal under cap opening is broken or missing
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    Acesulfame potassium, art raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose and xanthan gum

    Questions or comments?
    Call 1-855-274-4122

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

    Made in India

    Code: TS/DRUGS/19/1993

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label

    NDC 58602-200-24
    For Ages 2 to 11 Years
    Children’s
    Ibuprofen
    Oral Suspension USP
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)
    Lasts up to
    8 hours
    Alcohol Free
    Berry Flavor
    4 FL OZ (120 mL)
    AUROHEALTH

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label

    NDC 58602-200-24
    For Ages 2 to 11 Years
    Children’s
    Ibuprofen
    Oral Suspension USP
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)
    Lasts up to
    8 hours
    Alcohol Free
    Berry Flavor
    4 FL OZ (120 mL)
    AUROHEALTH


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (120 mL) Carton Label

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-200
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    RASPBERRY (UNII: 4N14V5R27W)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color ORANGE (Light orange to orange) Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58602-200-24 1 in 1 CARTON 04/17/2018
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:58602-200-20 1 in 1 CARTON 04/17/2018
    2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA209179 04/17/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    Name Address ID/FEI Business Operations
    IOL Chemicals and Pharmaceuticals Limited 677605646 API MANUFACTURE(58602-200)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 918917642 ANALYSIS(58602-200) , MANUFACTURE(58602-200)
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