Label: CHILDRENS FLANAX ORAL- ibuprofen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 30, 2024

If you are a consumer or patient 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. 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 to 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 (year) Dose (mL)*
     under 24 lbsunder 2 years ask a doctor 
    24-35 lbs  2-3 years5 mL 
    36-47 lbs 4-5 years 7.5 mL 
    48-59 lbs  6-8 years10 mL 
     60-71 lbs 9-10 years12.5 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 carton is opened or seal under cap opening is broken or missing • see bottom panel for lot number and expiration date

  • Inactive ingredients

    Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum

  • Questions or comments?

    1-888-779-2877
    9AM-5PM EST Mon-Fri.

  • SPL UNCLASSIFIED SECTION

    LASTS UP TO 8 HOURS

    for kids

    Berry Flavor
    Alcohol Free

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

    KEEP IN OUTER CARTON UNTIL CONTENTS USED

    Distributed by: Belmora LLC,
    3033 Wilson Blvd., Suite 700, Arlington, VA 22201
    Made in India

    Code: AP/DRUGS/04/2016

  • Packaging

    FLANAX-777

  • INGREDIENTS AND APPEARANCE
    CHILDRENS FLANAX ORAL 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-777
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    CHERRY (UNII: BUC5I9595W)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-777-991 in 1 CARTON01/26/2024
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20917901/26/2024
    Labeler - Belmora LLC (112753244)