Label: CHILDRENS ADVIL- ibuprofen suspension

  • NDC Code(s): 0573-1174-12
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 8, 2024

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, 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

    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

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

  • Questions or comments?

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

  • Additional Information

    Long Lasting: Up to 8 hours of fever reduction

    Great Convenience: Long duration means fewer doses needed per day.

    Alcohol-Free

    For most recent production information,

    Visit www.Advil.com

    Pfizer, Madison, NJ 07940 USA © 2019 Pfizer Inc.

    Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years – 11 years.

    Packaged with Tamper-Evident bottle cap.

    Do Not Use if breakable ring is separated or missing.

  • PRINCIPAL DISPLAY PANEL

    NDC0573-1174-12

    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

    Same Great Flavor!
    Now Dye-Free

    Dye-Free

    BLUE RASPBERRY

    Blue Raspberry-Flavored Liquid
    for ages 2-11 years

    4 FL OZ (120 mL)
    Alcohol-Free

    PAA105480 Front Carton

    Children's Advil Suspension BR Dye-Free 4 FL oz (120 mL)
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ADVIL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1174
    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 (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)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (Translucent) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-1174-121 in 1 CARTON09/30/2019
    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
    Labeler - Haleon US Holdings LLC (079944263)