Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

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Ibuprofen

Shopko Stores Operating Co., LLC

Shopko Ibuprofen Tablets 200 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Ibuprofen 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 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)

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

    Ibuprofen 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

    Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

    Questions or comments?

    1-800-719-9260

    Principal Display Panel

    Compare to Motrin® IB active ingredient

    Ibuprofen

    Tablets 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    See New Warnings Information

    Actual Size

    50 Coated Tablets

    Ibuprofen

    Ibuprofen TABLET, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:37012-074
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    IBUPROFEN IBUPROFEN 200 mg

    Inactive Ingredients

    Ingredient Name Strength
    SILICON DIOXIDE
    STARCH, CORN
    CROSCARMELLOSE SODIUM
    FD&C RED NO. 40
    FD&C YELLOW NO. 6
    cellulose, microcrystalline
    POLYETHYLENE GLYCOLS
    POLYVINYL ALCOHOL
    STEARIC ACID
    talc
    titanium dioxide
    ferric oxide red
    FERRIC OXIDE YELLOW

    Product Characteristics

    Color Size Imprint Code Shape
    ORANGE 10 mm I2 ROUND

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 50 in 1 BOTTLE
    2 NDC:37012-074-71 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077349 2013-08-19


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    Be sure to consult your doctor before taking any medication!
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