GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [PROFICIENT RX LP]

GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [PROFICIENT RX LP]
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NDC 63187-856-24
Set ID fcecd55a-afee-4998-b13d-ff49c83f7119
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number ANDA076359
  • Active ingredient (in each tablet)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    reduces fever
    relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
  • 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

    mouth or throat burning may occur; give with food or water
    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

    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

    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
    find the right dose on chart below. If possible, use weight to dose; otherwise use age.
    if needed, repeat dose every 6-8 hours
    do not use more than 4 times a day

    Dosing Chart

    Weight (lb)

    Age (yr)

    Tablets

    under 24

    under 2

    ask a doctor

    24-35

    2-3

    1

    36-47

    4-5

    1 ½

    48-59

    6-8

    2

    60-71

    9-10

    2 ½

    72-95

    11

    3

  • Other information

    phenylketonurics: contains phenylalanine 6 mg per tablet
    do not use if printed seal under cap is broken or missing
    store at 20-25°C (68-77°F)
    see end panel for lot number and expiration date
  • Inactive ingredients

    acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    For Ages 2 to 11

    See New Warnings Information

    Junior Strength Ibuprofen Tablets, 100 mg

    Lasts Up To 8 Hours

    Pain Reliever / Fever Reducer (NSAID)

    Orange Flavor

    Compare to active ingredient of Motrin® Junior Strength

    Manufactured by:

    Perrigo Allegan, MI 49010

    Relabeled by:

    Proficient Rx LP Thousand Oaks, CA 91320

    63187-856-24

    Junior Strength Ibuprofen Tablets, 100 mg Carton Image 1

    Junior Strength Ibuprofen Tablets, 100 mg Carton Image 2

    Junior Strength Ibuprofen Tablets, 100 mg Carton Image 2

  • INGREDIENTS AND APPEARANCE
    GOOD SENSE IBUPROFEN 
    ibuprofen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-856(NDC:0113-0461)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize13mm
    FlavorORANGEImprint Code L461
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-856-241 in 1 CARTON06/01/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07635911/09/2004
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-856)