Home > Drugs A-Z > INFANTS ADVIL

INFANTS ADVIL (Pfizer Consumer Healthcare)

Available Formats

Dosage Form Package Information Links
SUSPENSION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) > 15 mL in 1 BOTTLE, DROPPER Label Information
SUSPENSION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) > 30 mL in 1 BOTTLE, DROPPER Label Information

Complete INFANTS ADVIL Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)1


    1
    • nonsteroidal anti-inflammatory drug

  • Purpose

    Fever reducer/Pain reliever


  • Uses

    temporarily:

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

    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 the body
      • slurred speech
      • leg swelling
    • 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
    • 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 with the dosing device provided. Do not use with any other device.
    Dosing Chart
    Weight (lb) Age (mos) Dose (mL)
    under 6 mos ask a doctor
    12-17 lb 6-11 mos 1.25 mL
    18-23 lb 12-23 mos 1.875 mL

  • Other Information

    • 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

    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


  • Questions or comments?

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

    For most recent product information, visit www.Advil.com.


  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

    Infants'
    Advil®
    Concentrated Drops

    Ibuprofen Oral Suspension
    50 mg per 1.25 mL
    Pain Reliever/Fever Reducer (NSAID)

    White Grape-Flavored Drops

    1/2 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Infants'
    Advil®
    Concentrated Drops

    Ibuprofen Oral Suspension
    50 mg per 1.25 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains

    Lasts Up To
    8
    Hours

    Dye-Free

    White Grape Flavored Drops
    for ages 6–23 months

    1/2 FL OZ (15 mL)
    Alcohol-Free

    Principal Display Panel - 15 mL Bottle Carton

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    Infants'
    Advil®
    Concentrated Drops

    Ibuprofen Oral Suspension
    50 mg per 1.25 mL
    Pain Reliever/Fever Reducer (NSAID)

    White Grape-Flavored Drops

    1 FL OZ (30 mL)

    Principal Display Panel - 30 mL Bottle Label

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    VALUE Size

    Infants'
    Advil
    ®
    Concentrated Drops

    Ibuprofen Oral Suspension
    50 mg per 1.25 mL
    Pain Reliever/Fever Reducer (NSAID)

    Fever

    Aches & Pains

    Lasts Up To
    8
    Hours

    Dye-Free

    White Grape Flavored Drops
    for ages 6–23 months

    1 FL OZ (30 mL)
    Alcohol-Free

    Principal Display Panel - 30 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    INFANTS ADVIL 
    ibuprofen suspension/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0191
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg  in 1.25 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 WHITE (Translucent off-white) Score     
    Shape Size
    Flavor GRAPE (White grape) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0191-20 1 in 1 CARTON 01/30/1998
    1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2 NDC:0573-0191-50 1 in 1 CARTON 01/30/1998
    2 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3 NDC:0573-0191-22 1 in 1 CARTON 01/30/2014
    3 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4 NDC:0573-0191-75 1 in 1 CARTON 01/30/1998
    4 22.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020812 01/30/1998
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Canada Inc. 246770197 ANALYSIS(0573-0191) , LABEL(0573-0191) , MANUFACTURE(0573-0191) , PACK(0573-0191)