Label: CHILDRENS MOTRIN- ibuprofen suspension

  • NDC Code(s): 50580-601-04, 50580-601-08, 50580-601-20, 50580-601-21, view more
    50580-601-22, 50580-601-25
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 14, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL)

    Ibuprofen 100 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever/fever reducer

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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.

    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

    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

    Ask a doctor or pharmacist before use if the child is

    • 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

    • 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

    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 6-8 hours
    • do not use more than 4 times a day
    • replace original bottle cap to maintain child resistance
    Dosing Chart
    Weight (lb) Age (yr) Dose (mL)*
    *
    or as directed by a doctor
    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 20-25°C (68-77°F)
    • do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
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  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

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  • Questions or comments?

    Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

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  • PRINCIPAL DISPLAY PANEL

    See New Warnings

    NDC 50580-601-20

    For Ages 2 to 11 Years

    Children's
    Motrin
    ®

    contains Ibuprofen
    Oral Suspension
    (NSAID)
    100 mg per 5 mL

    Pain Reliever / Fever Reducer

    Lasts up to
    8 hours

    Alcohol Free

    Original
    Berry Flavor

    4 fl oz (120 mL)

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS MOTRIN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-601
    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)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-601-08 2 in 1 PACKAGE 01/30/2002
    1 NDC:50580-601-04 1 in 1 CARTON
    1 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    2 NDC:50580-601-21 1 in 1 CARTON 03/01/2012
    2 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    3 NDC:50580-601-22 1 in 1 CARTON 03/01/2012
    3 30 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    4 NDC:50580-601-20 1 in 1 CARTON 03/01/2012
    4 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    5 NDC:50580-601-25 2 in 1 PACKAGE 07/10/2012
    5 NDC:50580-601-20 1 in 1 CARTON
    5 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020516 09/01/1995
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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