Label: SHOPRITE IBUPROPHEN- ibuprofen tablet, coated 

  • Label RSS
  • NDC Code(s): 41190-647-71, 41190-647-78, 41190-647-85
  • 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 caplet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    muscular aches
    minor pain of arthritis
    toothache
    backache
    the common cold
    menstrual cramps
    temporarily reduces fever
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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 chances are higher if you

    are age 60 or older
    have had stomach ulcers or bleeding problems
    take a blood thinning (anticoagulant) or steroid drug
    take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    have 3 or more alcoholic drinks every day while using this product
    take more or for a longer time than directed

    Do not use

    if you have ever had an allergic reaction to any other pain reliever/fever reducer
    right before or after heart surgery

    Ask a doctor before use if

    you have problems or serious side effects from taking pain relievers or fever reducers
    the stomach bleeding warning applies to you
    you have a history of stomach problems, such as heartburn
    you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    you have asthma
    you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    under a doctor’s care for any serious condition
    taking any other drug

    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

    Stop use and ask a doctor if

    you experience any of the following signs of stomach bleeding:
    feel faint
    vomit blood
    have bloody or black stools
    have stomach pain that does not get better
    pain gets worse or lasts more than 10 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present in the painful area
    any new symptoms appear

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    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

    do not take more than directed
    the smallest effective dose should be used

    adults and children 12 years and

    older

    take 1 caplet every 4 to 6 hours while symptoms persist
    if pain or fever does not respond to 1 caplet, 2 caplets may be used
    do not exceed 6 caplets in 24 hours, unless directed by a doctor

    children under 12 years

    ask a doctor
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  • Other information

    read all warnings and directions before use
    store at 20-25°C (68-77°F)
    avoid high humidity and excessive heat above 40°C (104°F)
    see end panel for lot number and expiration date
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  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-SHOPRITE

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  • Principal Display Panel

    Compare to: Active Ingredient in Advil®

    SEE NEW WARNINGS INFORMATION

    IBUPROFEN Tablets USP, 200mg

    Pain Reliever – Fever Reducer (NSAID)

    FOR BODY ACHES AND PAINS

    actual size

    100 coated caplets**

    **(capsule shaped tablets)

    ShopRite Ibuprofen.jpg
    ShopRite Ibuprofen.jpg
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  • INGREDIENTS AND APPEARANCE
    SHOPRITE IBUPROPHEN 
    ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41190-647
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    CELLULOSE, MICROCRYSTALLINE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    Product Characteristics
    Color BROWN Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code I2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41190-647-71 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:41190-647-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    3 NDC:41190-647-85 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA072096 08/06/2013
    Labeler - Wakefern Food Corporation (069722418)
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