Label: GOOD SENSE IBUPROFEN- ibuprofen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 10, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purposes

    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

    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

    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

    mouth or throat burning may occur; give with food or water
    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
    find 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
    store between 20-25°C (68-77°F)
    do not use if printed seal under cap is broken or missing
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    For Ages 2 to 11 Years

    See New Warnings

    Junior Strength Ibuprofen Tablets, 100 mg

    Pain Reliever / Fever Reducer (NSAID)

    Orange Flavor

    Lasts Up To 8 Hours

    24 Chewable Tablets

    Compare to active ingredient of Motrin® Junior Strength

    100% SATISFACTION GUARANTEED

    461C2--junior-ibuprofen.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE IBUPROFEN 
    ibuprofen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (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)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeROUNDSize13mm
    FlavorORANGEImprint Code L461
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0461-621 in 1 CARTON11/09/2004
    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 - L. Perrigo Company (006013346)