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Ibuprofen (Atlantic Biologicals Corps)

Available Formats

Dosage Form Package Information Links
SUSPENSION 5 mL in 1 CUP (17856-5309-5) Label Information

Complete Ibuprofen Information

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug


  • Purposes

    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
    • 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
    • mL = milliliter; tsp = teaspoonful
    • 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
    • wash dosage cup after each use

    Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL or tsp)**

    under 24 lbs

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    5 mL (1 tsp)

    36-47 lbs

    4-5 years

    7.5 mL (1½ tsp)

    48-59 lbs

    6-8 years

    10 mL (2 tsp)

    60-71 lbs

    9-10 years

    12.5 mL (2½ tsp)

    72-95 lbs

    11 years

    15 mL (3 tsp)

    **or as directed by a doctor


  • Other information

    • each 5 mL (1 tsp) contains: sodium 2 mg
    • do not use if printed neckband is broken or missing
    • store at 20-25 C (68-77 F) ° °
    • do not freeze
    • 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


  • IBUPROFEN SUSPENSION

    Label Image

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5309(NDC:0904-5309)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    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
    Color ORANGE Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17856-5309-1 5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    2 NDC:17856-5309-2 10 mL in 1 SYRINGE; Type 0: Not a Combination Product
    3 NDC:17856-5309-3 1 mL in 1 SYRINGE; Type 0: Not a Combination Product
    4 NDC:17856-5309-4 20 mL in 1 CUP; Type 0: Not a Combination Product
    5 NDC:17856-5309-5 5 mL in 1 CUP; Type 0: Not a Combination Product
    6 NDC:17856-5309-6 15 mL in 1 CUP; Type 0: Not a Combination Product
    7 NDC:17856-5309-7 7.5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    8 NDC:17856-5309-9 1 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 02/07/1999
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    Name Address ID/FEI Business Operations
    Atlantic Biologicals Corps 047437707 RELABEL(17856-5309) , REPACK(17856-5309)