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being well ibuprofen (Save-A-Lot Food Stores Ltd)

Available Formats

Dosage Form Package Information Links
SUSPENSION 1 BOTTLE in 1 CARTON (46994-897-26) > 120 mL in 1 BOTTLE Label Information

Complete being well ibuprofen Information

  • Active ingredient (in each 5 mL)

    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
     
    • 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
    • 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, 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
    • 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
    • wash dosage cup after each use

    Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL)**

    under 24 lbs

    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 information

    • each 5 mL 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

  • 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


  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT OF CHILDREN’S MOTRIN®

    For Ages 2 to 11 Years

    CHILDREN’S Ibuprofen

    ORAL SUSPENSION

    100 mg per 5 mL

    PAIN RELIEVER/FEVER REDUCER

    (NSAID)

    Lasts up to 8 hours

    Alcohol Free

    Gluten Free

    Berry Flavor

    See New Warnings

    BEING WELL®

    4 FL OZ (120 mL)

    897-sm-children's ibuprofen.jpg

  • INGREDIENTS AND APPEARANCE
    BEING WELL IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-897
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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:46994-897-26 1 in 1 CARTON 02/25/2006
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074937 02/25/2006
    Labeler - Save-A-Lot Food Stores Ltd (095484572)