Label: CHILDRENS ADVIL- ibuprofen suspension

  • NDC Code(s): 0573-0170-01, 0573-0170-30, 0573-0170-32, 0573-0171-03, view more
    0573-0171-30, 0573-0171-32, 0573-0174-30, 0573-0207-30, 0573-0232-30, 0573-0290-01, 0573-0290-30
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 11, 2020

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

  • ACTIVE INGREDIENT (IN EACH 5 ML)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Fever reducer/Pain reliever

  • USES

    temporarily:

    reduces fever
    relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
  • 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 the 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 any other pain reliever/fever reducer
    right before or after heart surgery

    Ask a doctor before use if

    stomach bleeding warning applies to the child
    child has problems or serious side effects from taking pain relievers or fever reducers
    child has a history of stomach problems, such as heartburn
    child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or had a stroke
    child has not been drinking fluids
    child has lost a lot of fluid due to vomiting or diarrhea
    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.

  • 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 below. If possible, use weight to dose; otherwise use age.
    repeat dose every 6-8 hours, if needed
    do not use more than 4 times a day
    measure only with the dosing cup provided. Dosing cup to be used with Children's Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

    Dosing Chart

    Weight (lb)Age (yr)Dose (mL)

    under 24 lb

    under 2 yr

    ask a doctor

    24-35 lb

    2-3 yr

    5 mL

    36-47 lb

    4-5 yr

    7.5 mL

    48-59 lb

    6-8 yr

    10 mL

    60-71 lb

    9-10 yr

    12.5 mL

    72-95 lb

    11 yr

    15 mL

  • OTHER INFORMATION

    Children's Advil Suspension Fruit Flavor; Children's Advil Suspension Grape Flavor; Children's Advil Suspension White Grape Flavor; Children's Advil Bubblegum

    each 5 mL contains: sodium 3 mg
    one dose lasts 6-8 hours
    store at 20-25°C (68-77°F)
    see bottom of box for lot number and expiration date

    Children's Advil Suspension Blue Raspberry Flavor; Children's Advil Suspension Sugar-Free Dye-Free Berry Flavor

    each 5 mL contains: sodium 10 mg
    one dose lasts 6-8 hours
    store at 20-25°C (68-77°F)
    see bottom of box for lot number and expiration date
  • INACTIVE INGREDIENTS

    Children's Advil Suspension Fruit Flavor

    artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

    Children's Advil Suspension Grape Flavor

    acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

    Children's Advil Suspension Blue Raspberry Flavor

    artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum

    Children's Advil Suspension White Grape Flavor

    acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

    Children's Advil Suspension Bubblegum Flavor

    carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, natural and artificial flavor, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

    Children's Advil Suspension Sugar-Free Dye-Free Berry

    artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

  • QUESTIONS OR COMMENTS?

    call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0174-30

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains
    Lasts Up To
    8
    Hours

    BLUE
    RASPBERRY!

    Blue Raspberry-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Blue Raspberry-Flavored
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0171-30

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains
    Lasts Up To
    8
    Hours

    Grape-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Grape-Flavored
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0170-30

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains

    Lasts Up To
    8
    Hours

    Fruit-Flavored Liquid
    for ages
    2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Fruit-Flavored
  • PRINCIPAL DISPLAY PANEL

    NDC0573-0290-30

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains
    Lasts Up To
    8
    Hours

    Dye-Free
    WHITE GRAPE

    White Grape-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - White Grape-Flavored
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0207-30

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains
    Lasts Up To
    8
    Hours

    Bubble
    Gum

    Bubble Gum-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Bubble Gum-Flavored
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0232-30

    SUGAR-FREE

    Children's
    Advil®
    Suspension

    Ibuprofen Oral Suspension
    100 mg per 5 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains
    Lasts Up To
    8
    Hours

    Dye-Free
    BERRY

    Berry-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Berry-Flavored
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0174
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUE (Translucent, medium dark blue) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0174-301 in 1 CARTON06/27/1996
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058906/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0171
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLE (Translucent purple) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0171-301 in 1 CARTON06/27/1996
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0573-0171-031 in 1 CARTON06/27/1996
    230 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:0573-0171-322 in 1 PACKAGE06/27/1996
    31 in 1 CARTON
    3120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058906/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0170
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorRED (Translucent red) Score    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0170-301 in 1 CARTON06/27/1996
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0573-0170-011 in 1 CARTON06/27/1996
    230 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:0573-0170-321 in 1 CARTON06/27/1996
    3120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058906/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0290
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0290-301 in 1 CARTON12/01/2010
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0573-0290-011 in 1 CARTON12/01/2010
    230 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058912/01/2010
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0207
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0207-301 in 1 CARTON09/04/2012
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058909/04/2012
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0232
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0232-301 in 1 CARTON12/20/2013
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02058912/20/2013
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Consumer Healthcare LLC828831730ANALYSIS(0573-0170, 0573-0171, 0573-0174, 0573-0207, 0573-0232, 0573-0290)