Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 68094-494-58, 68094-494-59, 68094-494-61, 68094-494-62, view more
    68094-503-59, 68094-503-61, 68094-503-62
  • Packager: Precision Dose Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 23, 2016

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

  • SPL UNCLASSIFIED SECTION

    100 mg/5 mL 200 mg/10 mL

    For Hospital Use Only

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient (in each 5 mL = 1 teaspoonful)

    Ibuprofen 100 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
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  • Purposes

    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
    • This product is intended for use in children.
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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
    • blisters
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash

    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

    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 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, or kidney disease
    • 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

    • give with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    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
    • 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

    • use as directed per healthcare professional
    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • shake cups well before using
    • if needed, repeat dose every 6 - 8 hours
    • do not use more than 4 times a day
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  • Other Information

    • each teaspoon contains: sodium 2 mg
    • store at 20-25°C (68-77°F)
    • do not freeze
    • See individual label or shipper label for lot number and expiration date.
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  • Inactive Ingredients

    anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

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  • SPL UNCLASSIFIED SECTION

    Alcohol Free, Gluten Free

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  • How Supplied

    NDC 68094-494-58
    5 mL per unit dose syringe
    Fifty (50) unit dose syringes per shipper

    NDC 68094-494-61
    5 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-494-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-503-61
    10 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-503-62
    10 mL per unit dose cup
    Thirty (30) cups per shipper

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  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Perrigo Company
    515 Eastern Avenue
    Allegan, MI 49010

    Packaged By:
    Precision Dose, Inc.
    722 Progressive Lane
    S. Beloit, IL 61080

    LI 587
    Rev. 04/13

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  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC# 68094-494-58

    Children's IBUPROFEN Oral Suspension, 100 mg/5 mL

    Delivers 5 mL
    (NSAID)
    For Hospital Use Only

    Each 5 mL contains: sodium 2 mg

    Alcohol Free
    Gluten Free

    Store at 20°-25°C (68°-77°F)
    Protect from freezing

    Pkg: Precision Dose, Inc. S. Beloit, IL 61080

    LSY495 Rev. 04/11

    For Oral Use Only

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
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  • PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Lid

    NDC 68094-503-59

    PrecisionDoseā„¢

    Children's IBUPROFEN
    Oral Suspension
    200 mg/10 mL

    Delivers 10 mL Shake Well (NSAID) Alcohol Free Gluten Free
    Each 5 mL contains: sodium 2 mg

    Hospital Use Only
    Store at 20-25°C (68-77°F)
    Pkg. By: Precision Dose, Inc.
    S. Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Lid
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-494
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
    FD&C red NO. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    hypromelloses (UNII: 3NXW29V3WO)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    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:68094-494-62 3 in 1 CASE
    1 10 in 1 TRAY
    1 NDC:68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2 NDC:68094-494-61 10 in 1 CASE
    2 10 in 1 TRAY
    2 NDC:68094-494-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3 NDC:68094-494-58 5 in 1 CASE
    3 10 in 1 BAG
    3 5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 04/13/2004
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-503
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 200 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
    FD&C red NO. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    hypromelloses (UNII: 3NXW29V3WO)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    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:68094-503-62 3 in 1 CASE
    1 10 in 1 TRAY
    1 NDC:68094-503-59 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2 NDC:68094-503-61 10 in 1 CASE
    2 10 in 1 TRAY
    2 NDC:68094-503-59 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 09/14/2006
    Labeler - Precision Dose Inc. (035886746)
    Establishment
    Name Address ID/FEI Business Operations
    L. Perrigo Company 006013346 MANUFACTURE(68094-494, 68094-503)
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