IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]

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IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.]
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NDC 52959-298-04
Set ID d04a5ea0-0acd-4aaf-8d60-a6b08f3c04a8
Category HUMAN OTC DRUG LABEL
Packager H.J. Harkins Company, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA074937
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  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Ibuprofen 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
    • 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

    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 a doctor before use if

    • the 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 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
    • 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 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
    • wash dosage cup after each use
    Dosing Chart
    Weight (lb)Age(yrs)Dose (teaspoonful or mL)
    under 2 yearsask a doctor
    24-35 lbs2-3 years1 tsp or 5 mL
    36-47 lbs4-5 years1 ½ tsp or 7.5 mL
    48-59 lbs6-8 years2 tsp or 10 mL
    60-71 lbs9-10 years2 ½ tsp or 12.5 mL
    72-95 lbs11 years3 tsp or 15 mL
  • Other information

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

    anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

  • Questions or comments?


    1-800-719-9260


    Relabeled by:

    H.J. Harkins Company, Inc.

    Nipomo, CA 93444

  • Principal Display Panel

    For Ages 2 to 11

    Children’s Ibuprofen Oral Suspension

    100 mg per 5 mL (teaspoonful)

    Pain Reliever

    Fever Reducer (NSAID)

    Lasts up to 8 hours

    See New Warnings Information

    Berry Flavored Liquid

    Alcohol Free

    Children's

    COMPARE TO the active ingredient of CHILDREN'S MOTRIN®

    Children's Ibuprofen Oral Suspension Carton Image 1

    Children's Ibuprofen Oral Suspension Carton Image 1

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-298(NDC:0904-5309)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-298-041 in 1 CARTON
    1240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07493702/07/1999
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack, relabel
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