Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 9, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    (in each 5 mL)
    Ibuprofen, USP 100 mg (NSAID)**
    **nonsteroidal anti-inflammatory drug

  • Purpose

    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, 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

    • 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

    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

     Dosing Chart 
      Weight (lb) Age (yr)  Dose (mL)*
    under 24 under 2 years ask a doctor
     24-35 lbs 2-3 years 5 mL
     36-47 lbs4-5 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 years15 mL
    *or as directed by a doctor  
  • Other information

    each 5 mL contains: sodium 2 mg
    • store between 20° to 25°C (68° to 77°F)
    do not use if printed neckband is broken or missing
    • see bottom panel for lot number and expiration date

  • Inactive ingredients

    Original Berry: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Dye-Free Berry: citric acid, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Grape: citric acid, D&C red #33, FD&C blue #1, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

    Bubble Gum: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

  • QUESTIONS

    Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4217(NDC:0472-1263)
    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)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4217-4120 mL in 1 BOX; Type 1: Convenience Kit of Co-Package01/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07491607/01/2008
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4217)