Shoprite ibuprofen tablet, film coated

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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 doctors 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)

Directions

  • do not take more than directed
  • the smallest effective dose should be used
take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctorask a doctor

    adults and children 12 years and older

    children under 12 years

    Other information

    • read all warnings and directions before use
    • store at 20-25C (68-77F)
    • avoid high humidity and excessive heat above 40C (104F)
    • see end panel for lot number and expiration date {For Carton Configuration Only}

    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

    Questions or comments?

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    Ingredients and appearance - Product information

    Shoprite ibuprofen tablet, film coated- Ibuprofen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41190-604
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Ibuprofen ( UNII: WK2XYI10QM)( Ibuprofen - UNII: WK2XYI10QM ) 200 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Silicon dioxide ( UNII: ETJ7Z6XBU4)
    Starch, corn ( UNII: O8232NY3SJ)
    Croscarmellose sodium ( UNII: M28OL1HH48)
    Hypromellose, unspecified ( UNII: 3NXW29V3WO)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Titanium dioxide ( UNII: 15FIX9V2JP)
    Polysorbate 80 ( UNII: 6OZP39ZG8H)
    Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
    Ferric oxide red ( UNII: 1K09F3G675)
    Ferric oxide yellow ( UNII: EX438O2MRT)

    Product Characteristics

    Color BROWN Size 10 mm
    Shape ROUND Score 1
    Imprint Code I2

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA072096 USA

    Labeler - Wakefern Food Corporation( 069722418)

    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

    50 coated tablets