Label: CHILDRENS IBUPROFEN- ibuprofen suspension

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

Drug Label Information

Updated November 14, 2023

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

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Ibuprofen 100 mg (NSAID)1 


    1
    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
    • if needed repeat dose every 6–8 hours
    • do not use more than 4 times a day
    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° to 25°C (68° to 77°F)

    Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:

    NDC 0121-1022-05: 5 mL unit dose cup, in a tray of ten cups.

  • INACTIVE INGREDIENT

    Inactive ingredients: Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

  • QUESTIONS

    Questions or comments? Call 1-800-845-8210.

  • SPL UNCLASSIFIED SECTION

    *All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Children's Motrin® Dye-Free Berry Flavor.

    PACKAGED BY
    PAI Pharma
    Greenville, SC 29605

    R07/23

  • Principal Display Panel

    Delivers 5 mL
    NDC 0121-1022-05

    Children's Ibuprofen
    Oral Suspension, USP
    (NSAID)

    100 mg per 5 mL

    Pain Reliever/Fever Reducer
    Berry Flavored/Dye Free/Alcohol Free

    SHAKE WELL

    Package Not Child-Resistant

    PAI Pharma
    Greenville, SC 29605

    SEE DRUG FACTS

    Children's Ibuprofen Oral Suspension USP - 5mL lidding label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1022(NDC:76281-128)
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1022-0510 in 1 TRAY11/03/2023
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21060211/03/2023
    Labeler - PAI Holdings, LLC (044940096)