Label: CHILDRENS IBUPROFEN 572- ibuprofen suspension/ drops

  • NDC Code(s): 55319-929-03
  • Packager: Family Dollar Services, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 18, 2024

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

  • ACTIVE INGREDIENT (in each 5 mL)

    Ibuprofen, USP 100 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/fever reducer

  • USE(S)

    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
    • asthma (wheezing)
    • skin reddening
    • facial swelling
    • shock
    • 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


    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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • STOP USE AND ASK 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
    • 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

    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 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
    • store between 20-25oC (68-77oF)
    • do not use if carton is opened or if printed inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing.
  • INACTIVE INGREDIENTS

    anhydrous citric acid, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum.

  • QUESTIONS OR COMMENTS?

    Call 1-609-860-2600 (Monday-Friday 8 am -4 pm)

  • PRINCIPAL DISPLAY PANEL

    FAMILY Wellness

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S MOTRIN®*
    Children's Ibuprofen

    Oral Suspension

    Ages 2 to 11 Years

    USP 100 mg per 5 mL

    Pain Reliever/Fever Reducer

    (NSAID)

    8 Hour

    Alcohol Free

    BUBBLE GUM FLAVOR

    4 FL OZ (120mL)

    572-fw-label

      

    572-fw-carton

     


  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 572 
    ibuprofen suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-929
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-929-031 in 1 CARTON04/18/2024
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21014904/18/2024
    Labeler - Family Dollar Services, Inc. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(55319-929)