Label: SHOPRITE IBUPROFEN IB- ibuprofen tablet, chewable 

  • NDC Code(s): 41190-461-62
  • Packager: Wakefern Food Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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

  • Active ingredient (in each tablet)

    Ibuprofen 100 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily:

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

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  • 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

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  • 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
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  • 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, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

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  • Questions or comments?

    1-800-SHOPRITE

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  • Principal Display Panel

    Compare to: Active Ingredient in Motrin® Junior Strength

    SEE NEW WARNINGS INFORMATION

    Junior Strength

    AGES 2-11

    IBUPROFEN IB

    Ibuprofen Tablets, 100mg

    Pain Reliever – Fever Reducer (NSAID)

    Lasts up to 8 hours

    24 orange-flavored chewable tablets

    ShopRite Ibuprofen IB.jpg
    ShopRite Ibuprofen IB.jpg
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  • INGREDIENTS AND APPEARANCE
    SHOPRITE IBUPROFEN IB 
    ibuprofen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41190-461
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    CARNAUBA WAX  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MANNITOL  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    SOYBEAN OIL  
    SUCCINIC ACID  
    ACESULFAME POTASSIUM  
    Product Characteristics
    Color ORANGE Score 2 pieces
    Shape ROUND Size 13mm
    Flavor ORANGE Imprint Code L461
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41190-461-62 1 in 1 CARTON
    1 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076359 07/02/2013
    Labeler - Wakefern Food Corporation (069722418)
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