Label: CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension

  • 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 (NSAID)

  • PURPOSE

    Purpose
    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 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
    NSAlD, 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 lor a longer time than directed
    Heart attack and stroke warning: NSAlDs, 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 lor longer than directed.
    Sore throat warning: Severe or persistent sore throat or
    sore throat accompanied by high lever, 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
       heartbum
    ■ 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 lor any serious condition
    ■ taking any other drug

  • WHEN USING

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

  • STOP USE

    Slop 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 11 years

     15 mL

    *or as dIrected by a doctor

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 5 mL contains: sodium 2 mg
    ■ store between 20-25° C (68-77° F)
    ■ 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
    Acesullame 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 1-877-798-5944 from 9:30 AM to 4:30 PM EST,
    Monday-Friday.

  • Package Labeling

    For Ages 2 to 11 Years

    DISCOUNT
        drug
        mart
    FOOD FAIR

    Children's

    Ibuprofen

    Oral Suspension (NSAID)

    100 mg per 5mL

    DISCOUNT
        drug
        mart
    FOOD FAIR

    NDC 53943-119-24

    Compare To The
    Active Ingredient In
    Children's Motrin® **

    SEE NEW WARNINGS

    For Ages 2 to 11 Years

    Children's

    Ibuprofen

    Oral Suspension (NSAID)

    100 mg per 5mL

    Pain Reliever/Fever reducer

    LASTS UP TO 8 HOURS

    ALCOHOL FREE

    Original Berry Flavor

    4 FL OZ (118 mL)

    Important: Read all product information 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®.

    SATISFACTION GUARANTEED
    IF DISSATISFIED, RETURN UNUSED PORTION AND
    PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO
    RETURN TO STORE, SEND REASON FOR DISSATISFACTION,
    NAME, ADDRESS, AND EMPTY PACKAGE TO:
    DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    BX-082

    0  93351 02962  2

    01078436

    Box Label

    DDrugMart 53943-119 Box

    Bottle Label

    DDrugMart 53943-119 Botl

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN ORAL SUSPENSION 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-119
    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
    FlavorBERRY (Original) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-119-241 in 1 CARTON08/16/2019
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21060208/16/2019
    Labeler - Discount Drug Mart (047741335)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53943-119)