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: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 15, 2019

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

  • DRUG FACTS
  • ACTIVE INGREDIENT (IN EACH 5 ML)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Close
  • PURPOSE

    Fever reducer/Pain reliever

    Close
  • USES

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
    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 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.

    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 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
    Close
  • 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
    Close
  • 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

    Close
  • QUESTIONS OR COMMENTS?

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

    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Blue Raspberry-Flavored

    Do Not Use if breakable ring on bottle cap
    is separated or missing.

    Children's
    Advil
    ®
    Suspension

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

    Blue Raspberry-Flavored Liquid
    4 FL OZ (120 mL)

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

    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
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Grape-Flavored

    Do Not Use if breakable ring on bottle cap
    is separated or missing.

    Children's
    Advil
    ®
    Suspension

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

    Grape-Flavored Liquid
    4 FL OZ (120 mL)

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

    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
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Fruit-Flavored

    Children's
    Advil
    ®
    Suspension

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

    Fruit-Flavored Liquid
    4 FL OZ (120 mL)

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

    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
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - White Grape-Flavored

    Do Not Use if breakable ring on bottle cap
    is separated or missing.

    Children's
    Advil®
    Suspension

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

    White Grape-Flavored Liquid
    4 FL OZ (120 mL)

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

    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
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Bubble Gum-Flavored

    Do Not Use if breakable ring on bottle cap
    is separated or missing.

    Children's
    Advil
    ®
    Suspension

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

    Bubble Gum-Flavored Liquid
    4 FL OZ (120 mL)

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

    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
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Berry-Flavored

    Do Not Use if breakable ring on bottle cap
    is separated or missing.

    Children's
    Advil
    ®
    Suspension

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

    Sugar-Free Dye-Free
    Berry-Flavored Liquid
    4 FL OZ (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label - Berry-Flavored
    Close
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton - Berry-Flavored

    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
    Close
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0174
    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
    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
    Color BLUE (Translucent, medium dark blue) Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0174-30 1 in 1 CARTON 06/27/1996
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 06/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0171
    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
    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
    Color PURPLE (Translucent purple) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0171-30 1 in 1 CARTON 06/27/1996
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0573-0171-03 1 in 1 CARTON 06/27/1996
    2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0573-0171-32 2 in 1 PACKAGE 06/27/1996
    3 1 in 1 CARTON
    3 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 06/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0170
    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
    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
    Color RED (Translucent red) Score     
    Shape Size
    Flavor FRUIT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0170-30 1 in 1 CARTON 06/27/1996
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0573-0170-01 1 in 1 CARTON 06/27/1996
    2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0573-0170-32 1 in 1 CARTON 06/27/1996
    3 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 06/27/1996
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0290
    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
    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     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0290-30 1 in 1 CARTON 12/01/2010
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0573-0290-01 1 in 1 CARTON 12/01/2010
    2 30 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 12/01/2010
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0207
    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
    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
    Color PINK Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0207-30 1 in 1 CARTON 09/04/2012
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 09/04/2012
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0232
    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
    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     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0232-30 1 in 1 CARTON 12/20/2013
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020589 12/20/2013
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Registrant - Pfizer Inc (113480771)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Consumer Healthcare LLC 828831730 ANALYSIS(0573-0170, 0573-0171, 0573-0174, 0573-0207, 0573-0232, 0573-0290)
    Close