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

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

GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [PROFICIENT RX LP]
PDF | XML
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
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs