GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]

GOOD SENSE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [L. PERRIGO COMPANY]
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NDC 0113-0057-05
Set ID c79e65e7-149b-450f-b083-99e16ff71729
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA075217
  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer

  • Uses

    temporarily:

    reduces fever
    relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
  • 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

    give 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
    find right dose on chart below. If possible, use weight to dose; otherwise use age.
    mL = milliliter
    measure with the dosing device provided. Do not use with any other device.
    dispense liquid slowly into the child’s mouth, toward the inner cheek
    if needed, repeat dose every 6-8 hours
    do not use more than 4 times a day

    Dosing Chart

    Weight (lbs)

    Age (mos)

    Dose (mL)

    under 6 mos

    ask a doctor

    12-17 lbs

    6-11 mos

    1.25 mL

    18-23 lbs

    12-23 mos

    1.875 mL

  • Other information

    store at 20-25°C (68-77°F)
    do not freeze
    do not use if printed neckband is broken or missing
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    For Ages 6 to 23 mos.

    See New Warnings

    Infants'

    CONCENTRATED DROPS

    Ibuprofen Oral Suspension

    50 mg per 1.25 mL

    Pain Reliever/Fever Reducer (NSAID)

    Lasts Up To 8 Hours

    No High Fructose Corn Syrup

    Use Only With Enclosed Syringe

    Berry Flavor

    Compare to active ingredient of Motrin® Infants’ Drops

    100% SATISFACTION GUARANTEED

    0.5 FL OZ (15 mL)

    infants ibuprofen image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE IBUPROFEN  INFANTS
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN50 mg  in 1.25 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (light) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0057-051 in 1 CARTON02/08/2000
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07521702/08/2000
    Labeler - L. Perrigo Company (006013346)