Label: CHILDRENS IBUPROFEN- ibuprofen suspension

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

Drug Label Information

Updated January 1, 2019

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

  • ACTIVE INGREDIENT

    (in each 5 mL = 1 teaspoon)

    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
    shock
    asthma (wheezing)
    rash
    skin reddening
    blisters
    facial swelling

    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 any other pain reliever/fever reducer
    right before or after heart surgery
  • ASK 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, or kidney disease
    child has asthma
    child is taking a diuretic
  • ASK 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 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
    the child does not get any relief within the 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
    find right dose on chart.  If possible, use weight to dose; otherwise use age.
    use only enclosed measuring cup
    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 (tsp or mL)

    under 2 years

    ask a doctor

    24 – 35 lbs

    2 – 3 years

    1 tsp or 5 mL

    36 – 47 lbs

    4 – 5 years

    1½ tsp or 7.5 mL

    48 – 59 lbs

    6 – 8 years

    2 tsp or 10 mL

    60 – 71 lbs

    9 – 10 years

    2½ tsp or 12.5 mL

    72 – 95 lbs

    11 years

    3 tsp or 15 mL

    Other information

    each teaspoon contains: sodium 2 mg
    do not use if printed neckband is broken or missing
    store between 20 - 25°C (68 - 77°F)
    see bottom panel for lot number and expiration date
  • INACTIVE INGREDIENT

    Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.

  • QUESTIONS?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Children’s Motrin( Bubble Gum*

    NDC 63187-166-18

    For ages 2 to 11

    CHILDREN’S Ibuprofen Oral Suspension, USP

    (NSAID)

    100 mg per 5 mL (teaspoon)

    Pain Reliever

    Fever Reducer

    Lasts up to 8 hours

    Bubble Gum Flavor

    Alcohol Free

    4 FL OZ (118 mL)

     
    12630112F1 VC100162
    63187-166-18
  • INGREDIENTS AND APPEARANCE
    CHILDRENS IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-166(NDC:0472-1263)
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (light) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-166-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07491606/01/2006
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079502574REPACK(63187-166) , RELABEL(63187-166)