Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 0472-1255-94, 0472-1255-98, 0472-1261-94, 0472-1262-94, view more
    0472-1263-94
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 2, 2018

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

  • Drug Facts
  • Active ingredient

    (in each 5 mL)
    Ibuprofen, USP 100 mg (NSAID)**
    **nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • Uses

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

    Close
  • 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.

    Close
  • 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

    Close
  • 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

    Close
  • Ask a doctor or pharmacist before use if the child is

    • under a doctor’s care for any serious condition
    • taking any other drug

    Close
  • When using this product

    • take with food or milk if stomach upset occurs

    Close
  • 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

    Close
  • KEEP OUT OF REACH OF CHILDREN

    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)

    Close
  • 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)*
    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
    *or as directed by a doctor  
    Close
  • Other information

    each 5 mL contains: sodium 2 mg
    • store between 20° to 25°C (68° to 77°F)
    do not use if printed neckband is broken or missing
    • see bottom panel for lot number and expiration date

    Close
  • Inactive ingredients

    Original Berry: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Dye-Free Berry: citric acid, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Grape: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Bubble Gum: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Close
  • QUESTIONS

    Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

    Close
  • PRINCIPAL DISPLAY PANEL

    Actavis

    Compare to the active ingredient in Children’s Motrin® Berry† 

    NDC 0472-1255-94 

    See New Warnings

    For Ages 2 to 11 years
    Children’s Ibuprofen Oral Suspension, USP
    (NSAID)
    100 mg per 5 mL 

    Pain Reliever
    Fever Reducer 

    Lasts up to 8 hours  

    Shake Well
    Before Using 

    Original Berry Flavor 

    Alcohol Free 

    4 FL OZ (118 mL)

    original berry

    original berry

    Close
  • PRINCIPAL DISPLAY PANEL

    Actavis

    Compare to the active ingredient in Children’s Motrin® Dye Free Berry† 

    NDC 0472-1261-94 

    See New Warnings

    For Ages 2 to 11 years
    Children’s Ibuprofen Oral Suspension, USP
    (NSAID)
    100 mg per 5 mL 

    Pain Reliever
    Fever Reducer 

    Lasts up to 8 hours  

    Shake Well
    Before Using 

    Non-Staining
    Dye-Free Berry Flavor 

    Alcohol Free 

    4 FL OZ (118 mL)

    dye-free berry

    dye-free berry

    Close
  • PRINCIPAL DISPLAY PANEL

    Actavis

    Compare to the active ingredient in Children’s Motrin® Grape† 

    NDC 0472-1262-94 

    See New Warnings

    For Ages 2 to 11 years
    Children’s Ibuprofen Oral Suspension, USP
    (NSAID)
    100 mg per 5 mL 

    Pain Reliever
    Fever Reducer 

    Lasts up to 8 hours  

    Shake Well
    Before Using 

    Grape Flavor 

    Alcohol Free 

    4 FL OZ (118 mL)

    image
    Close
  • PRINCIPAL DISPLAY PANEL

    Actavis

    Compare to the active ingredient in Children’s Motrin® Bubble Gum† 

    NDC 0472-1263-94 

    See New Warnings

    For Ages 2 to 11 years
    Children’s Ibuprofen Oral Suspension, USP
    (NSAID)
    100 mg per 5 mL

    Pain Reliever
    Fever Reducer 

    Lasts up to 8 hours  

    Shake Well
    Before Using 

    Bubble Gum Flavor 

    Alcohol Free 

    4 FL OZ (118 mL)

    bubble gum

    bubble gum

    Close
  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1255
    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)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
    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:0472-1255-94 1 in 1 CARTON 06/16/2006 08/31/2019
    1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2 NDC:0472-1255-98 1 in 1 CARTON 04/30/1999 04/30/1999
    2 237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074916 04/30/1999 08/31/2019
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1261
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
    Product Characteristics
    Color WHITE (opaque) Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-1261-94 1 in 1 CARTON 07/11/2008 08/31/2019
    1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074916 07/11/2008 08/31/2019
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1262
    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 RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-1262-94 1 in 1 CARTON 04/30/1999 04/30/1999
    1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074916 04/30/1999 04/30/1999
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1263
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    Does not contain ALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
    Product Characteristics
    Color PINK Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-1263-94 1 in 1 CARTON 07/01/2008 08/31/2019
    1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074916 07/01/2008 08/31/2019
    Labeler - Actavis Pharma, Inc. (119723554)
    Close