IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]

IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]
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NDC 65162-672-86
Set ID ae1cb9ae-9d01-47f0-b9ec-0d924d913514
Category HUMAN OTC DRUG LABEL
Packager Amneal Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number ANDA200457
  • OTC - ACTIVE INGREDIENT

    Active Ingredient                               

    (in each 5 mL = 1 teaspoon)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • OTC - PURPOSE

    Purpose

    Pain reliever/ fever reducer

  • INDICATIONS AND USAGE

    Uses

    Temporarily:

    ■ Relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

    ■ Reduces fever

  • WARNINGS

    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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your child:

    ■ has had stomach ulcers or bleeding problems

    ■ takes a blood thinning (anticoagulant) or steroid drug

    ■ takes other drugs containing an NSAID (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.

  • OTC - DO NOT USE

    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

  • OTC - ASK DOCTOR

    Ask a doctor before use if:

    ■ child has problems or serious side effects from taking pain relievers or fever reducers

    ■ stomach bleeding warning applies to your child

    ■ child has a history of stomach problems, such as heartburn

    ■ 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

  • OTC - ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the child is:

    ■ under doctor’s care for any serious condition

    ■ taking any other drug

  • OTC - WHEN USING

    When using this product:

    ■ take 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

  • OTC - STOP USE

    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 the 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

  • OTC - KEEP OUT OF REACH OF CHILDREN

    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)

  • DOSAGE AND ADMINISTRATION

    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)

    ■ 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

    Dosing Chart

    Weight (lb) Age (yr)Dose (tsp or mL)
    under 2 years ask 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

    Other information

    ■ each teaspoon contains: sodium 2 mg

    ■ store between 20° to 25°C (68° to 77°F)

    ■ do not use if bottle wrap, or imprinted foil inner seal is broken or missing

    ■ see bottom panel for lot number and expiration date

  • INACTIVE INGREDIENTS

    acesulfame-potassium, anhydrous citric acid, D&C yellow # 10, FD&C red # 40, glycerin, NA bubble gum flavor FQ5511, polysorbate 80 (tween 80), purified water, sodium benzoate, sucrose, xanthan gum

  • OTC - QUESTIONS

    Questions or Comments? Call 1-877-835-5472,

    Monday through Friday 9AM - 5PM EST.

    Keep the carton.

    It contains important information.

    See end panel for expiration date.

    *This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Children’s Motrin®.

  • Distributed by: Amneal Pharmaceuticals

    Glasgow, KY 42141

    Rev. 07-2011

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    010ab916-figure-01
    010ab916-figure-02
    010ab916-figure-03
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  PAIN RELIEVER/ FEVER REDUCER
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-672
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-672-861 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20045711/12/2011
    Labeler - Amneal Pharmaceuticals (123797875)
    Registrant - Amneal Pharmaceuticals (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals968119730ANALYSIS, MANUFACTURE, LABEL, PACK

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