Label: IBUPROFEN CHILDRENS- ibuprofen suspension

  • NDC Code(s): 0363-0166-26, 0363-0166-28, 0363-0166-34, 0363-0166-40
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 6, 2019

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

  • Purposes

    Pain reliever/fever reducer

  • Uses

    temporarily:

    relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    reduces fever
  • 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 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

    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 ibuprofen or any other pain reliever/fever reducer
    right before or after heart surgery

    Ask a 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, or had a stroke
    child has asthma
    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

    give 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 of 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. (1-800-222-1222)

  • 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. If possible, use weight to dose; otherwise use age.
    use only enclosed dosing cup. Do not use any other dosing device.
    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
    wash dosage cup after each use
     
    Dosing Chart
     
    Weight (lb)
     
    Age (yr)
     
    Dose (mL)**
     
    under 24 lbs
     
    under 2 years
     
    ask a doctor
     
    24-35 lbs
     
    2-3 years
     
    5 mL
     
    36-47 lbs
     
    4-5 years
     
    7.5 mL
     
    48-59 lbs
     
    6-8 years
     
    10 mL
     
    60-71 lbs
     
    9-10 years
     
    12.5 mL
     
    72-95 lbs
     
    11 years
     
    15 mL
     
    ** or as directed by a doctor
  • Other information

    each 5 mL contains: sodium 2 mg
    do not use if printed neckband is broken or missing
    store at 20-25°C (68-77°F)
    do not freeze
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    TWIN PACK

    Compare to Children’s Motrin® active ingredient

    children’s

    Ibuprofen 100

    IBUPROFEN ORAL SUSPENSION

    100 mg PER 5 mL

    PAIN RELIEVER / FEVER REDUCER (NSAID)

    LASTS UP TO 8 HOURS

    ALCOHOL FREE

    AGES 2 TO 11 YEARS

    BUBBLE GUM FLAVOR

    2 – 4 FL OZ (118 mL) BOTTLES

    8 FL OZ (236 mL) TOTAL

    SEE NEW WARNINGS

    childrens ibuprofen image
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  CHILDRENS
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0166
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (light) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0166-261 in 1 CARTON03/04/2002
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0166-281 in 1 CARTON09/20/2013
    2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0166-403 in 1 CARTON03/04/2002
    3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0166-342 in 1 CARTON04/07/2008
    4118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07493703/04/2002
    Labeler - Walgreen Company (008965063)