IBUPROFEN ORAL SUSPENSION [NUCARE PHARMACEUTICALS,INC.]

IBUPROFEN ORAL SUSPENSION [NUCARE PHARMACEUTICALS,INC.]
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NDC 68071-1628-4
Set ID 84764eda-7446-5b16-e053-2991aa0abd7c
Category HUMAN OTC DRUG LABEL
Packager NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number ANDA210602
  • ACTIVE INGREDIENT(S)

    (in each 5 mL)
    Ibuprofen 100 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug


  • PURPOSE

    Pain reliever/fever reducer



  • USE(S)

    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 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

    • take 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

    Dosing Chart

      




    Weight (lb)
    under 24
    24-35 lbs
    36-47 lbs
    48-59 lbs
    60-71 lbs
    72-95 lbs 

      Age (yr)

    under 2 years
    2-3 years
    4-5 years
    6-8 years
    9-10 years
    11 years

      Dose (mL)*

    ask  a doctor
    5 mL
    7.5 mL
    10 mL
    12.5 mL
    15 mL



    *or as directed by a doctor 

  • Other information

    •  each 5 mL contains : sodium 2 mg
    •  store between 20-25°C (68-77°F)
    •   do not use if carton is opened or printed bottle neckband is broken or missing
    •  see bottom panel for lot number and expiration date
  • INACTIVE INGREDIENT SECTION


    Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum.

  • QUESTIONS SECTION


    Call 1-888-588-1418 from 9 AM to 5 PM EST,
    Monday-Friday.           




    ibuprofencamberlogo


    Distributed by:
    Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN ORAL 
    ibuprofen oral suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1628(NDC:69230-308)
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-1628-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21060211/23/2018
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-1628)

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