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 October 3, 2018

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

  • SPL UNCLASSIFIED SECTION

    Berry Flavor

    100 mg/5 mL  200 mg/10 mL

    For Hospital Use Only

    Drug Facts

  • Active ingredient (in each 5 mL)

    Ibuprofen 100 mg (NSAID)1


    1
    nonsteroidal anti-inflammatory drug
  • Purposes

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    • reduces fever
    • Important: Read all product information before using.
    • This product is intended for use in children.
  • 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

    • give 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)

  • 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
    • mL = milliliter
    • find right dose on chart. If possible, use weight to dose; otherwise use age.
    • if needed, repeat dose every 6-8 hours
    • do not use more than 4 times a day
    Dosing Chart
    Weight (lb)Age (yr)Dose (mL)*
    *
    or as directed by a doctor
    under 24 lbsunder 2 yearsask a doctor
    24-35 lbs2-3 years5 mL
    36-47 lbs4-5 years7.5 mL
    48-59 lbs6-8 years10 mL
    60-71 lbs9-10 years12.5 mL
    72-95 lbs11 years15 mL
  • Other information

    • each 5 mL contains: sodium 2 mg
    • store at 20-25°C (68-77°F)
    • do not freeze
    • See individual label or shipper for lot number and expiration date.
  • 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

  • SPL UNCLASSIFIED SECTION

    Alcohol Free, Gluten Free

  • How Supplied

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

  • SPL UNCLASSIFIED SECTION

    Distributed By
    Perrigo Company
    Allegan, MI 49010

    Packaged By
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI587   Rev. 02/18

  • 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
  • PRINCIPAL DISPLAY PANEL - 200 mg/10 mL Lid

    NDC 68094-503-59

    PrecisionDose™

    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
  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-494
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-494-623 in 1 CASE04/13/2004
    110 in 1 TRAY
    1NDC:68094-494-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:68094-494-6110 in 1 CASE04/13/2004
    210 in 1 TRAY
    2NDC:68094-494-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:68094-494-585 in 1 CASE04/13/2004
    310 in 1 BAG
    35 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07493704/13/2004
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-503
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-503-623 in 1 CASE09/14/2006
    110 in 1 TRAY
    1NDC:68094-503-5910 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:68094-503-6110 in 1 CASE09/14/2006
    210 in 1 TRAY
    2NDC:68094-503-5910 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07493709/14/2006
    Labeler - Precision Dose Inc. (035886746)
    Establishment
    NameAddressID/FEIBusiness Operations
    L. Perrigo Company006013346MANUFACTURE(68094-494, 68094-503)