Label: CHILDRENS IBUPROFEN- ibuprofen suspension

  • NDC Code(s): 63868-795-04, 63868-795-08
  • Packager: Chain Drug Marketing Association, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    (in each 5 mL)
    Ibuprofen 100 mg (NSAlD)*
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Ibuprofen .... Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses temporarily:
    ■ relieves minor aches and pains due to the common cold,
       flu, sore throat, headache and toothache
    ■ reduces fever

  • WARNINGS

    Warnings
    Allergy alert: Ibuprofen may cause asevere 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

    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 DOCTOR

    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 DOCTOR/PHARMACIST

    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

    When using this product
    ■ take with food or milk if stomach upset occurs

  • STOP USE

    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)

  • DOSAGE & ADMINISTRATION

    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 11years 15 mL

    * or as directed by a doctor

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 mL contains: sodium 2 mg
    ■ store between 20-25ºC (68-77ºF)
    ■ do not use if carton is opened or printed bottle
      neckband is broken or missing
    ■ see bottom panel for lot number and expiration date

  • INACTIVE INGREDIENT

    Inactive ingredients
    Acesulfame potassium, anhydrous citric acid,
    carboxymethylcellulose sodium, D&C Yellow #10, FD&C
    Red #40, flavors, glycerin, microcrystalline cellulose,
    polysorbate 80, propylene glycol, purified water, sodium
    benzoate, sucrose, and xanthan gum

  • QUESTIONS

    Questions or comments?
    Call 732-314-4550 from 9AM to SPM EST,
    Monday - Friday.

  • PRINCIPAL DISPLAY PANEL

    children's

    ibuprofen

    Oral  Suspension (NSAID)

    For Ages 2 to 11 Years

                                                 NDC 63868-795-04

    QC

    QUALITY CHOICE        See New Warnings

    Compare to the
    active ingredient in
    Children's Motrin​®

    children's
    ibuprofen

    Oral Suspension (NSAID)
    100 mg per 5 mL

    Pain Reliever/Fever Reducer

    8 HRS    Lasts up to
                  8 Hours

    For ages 2 to 11 years
    Alcohol Free

    Original Berry
    Flavor

    4 fl oz (118 mL)

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

    ** This product is not manufactured or distributed by McNeil
    Consumer Healthcare, distributor of Children's Motrin®.

    BX-117

    Distributed by C.D.M.A., Inc.©
    43157 W 9 Mile Rd
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

    4 OZ

    Berry 795-04 4OZBerry 795-04 4OZ

    8 OZ

    Berry 795-08 8OZBerry 795-08 8OZBerry 795-08 8OZ

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-795
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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
    ColororangeScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-795-041 in 1 CARTON12/15/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63868-795-081 in 1 CARTON12/15/2020
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21060212/15/2020
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(63868-795)