Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 68016-255-94, 68016-261-94, 68016-262-94, 68016-263-94
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 29, 2019

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

  • ACTIVE INGREDIENT

    (in each 5 mL = 1 teaspoon)
    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
    • shock
    • asthma (wheezing)
    • rash
    • skin reddening
    • blisters
    • facial swelling

    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.

    Close
  • 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
    Close
  • ASK 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
    Close
  • ASK 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
    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
    • the child does not get any relief within the 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

    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
    • find right dose on chart.  If possible, use weight to dose; otherwise use age.
    • use only enclosed measuring cup
    • 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 (tsp or mL)

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    1 tsp or 5 mL

    36-47 lbs

    4-5 years

    1 ½ tsp or 7.5 mL

    48-59 lbs

    6-8 years

    2 tsp or 10 mL

    60-71 lbs

    9-10 years

    2 ½ tsp or 12.5 mL

    72-95 lbs

    11 years

    3 tsp or 15 mL


    Close
  • OTHER INFORMATION

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

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

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

    Close
  • QUESTIONS?

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

    Close
  • Package Label - Original Berry Flavor

    NDC 68016-255-94 

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN®BERRY* 

    Premier Value® 

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

    • 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 label 

      

    Close
  • Package Label - Dye-Free Berry Flavor

    NDC 68016-261-94 

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® DYE FREE BERRY* 

    Premier Value® 

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

    • 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 label
    Close
  • Package Label - Grape Flavor

    NDC 68016-262-94 

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® GRAPE* 

    Premier Value® 

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

    • Pain Reliever
    • Fever Reducer

    Lasts up to 8 hours

    Shake Well
    Before Using

    Grape Flavor
    Alcohol Free
    4 fl oz (118 mL)

    grape flavor
    Close
  • Package Label - Bupple Gum Flavor

    NDC 68016-263-94 

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S MOTRIN® BUBBLE GUM* 

    Premier Value® 

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

    • 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 flavor

    Close
  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-255
    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:68016-255-94 1 in 1 CARTON 06/01/2006 08/01/2019
    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 06/01/2006 08/01/2019
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-261
    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:68016-261-94 1 in 1 CARTON 06/01/2006 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 06/01/2006 08/31/2019
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-262
    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:68016-262-94 1 in 1 CARTON 06/01/2006 06/01/2019
    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 06/01/2006 06/01/2019
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-263
    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:68016-263-94 1 in 1 CARTON 06/01/2006 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 06/01/2006 08/31/2019
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
    Close