Ibuprofen ib tablet, film coated

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  1. temporarily relieves minor aches and pains due to:
  2. headache
  3. muscular aches
  4. minor pain of arthritis
  5. toothache
  6. backache
  7. the common cold
  8. menstrual cramps
  9. temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  1. hives
  2. facial swelling
  3. asthma (wheezing)
  4. shock
  5. skin reddening
  6. rash
  7. 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

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

Do not use

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

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

  1. taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  2. under a doctors care for any serious condition
  3. taking any other drug

When using this product

  1. take with food or milk if stomach upset occurs
  2. 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

  1. you experience any of the following signs of stomach bleeding:
  2. feel faint
  3. vomit blood
  4. have bloody or black stools
  5. have stomach pain that does not get better
  6. pain gets worse or lasts more than 10 days
  7. fever gets worse or lasts more than 3 days
  8. redness or swelling is present in the painful area
  9. 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

  1. do not take more than directed
  2. the smallest effective dose should be used
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 doctorask a doctor

    adults and children 12 years and older

    children under 12 years

    Other information

    1. read all warnings and directions before use
    2. store at 20-25C (68-77F)
    3. avoid high humidity and excessive heat above 40C (104F)
    4. 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

    Ingredients and appearance - Product information

    Ibuprofen ib tablet, film coated- Ibuprofen

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42507-517
    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)
    Fd&c red no. 40 ( UNII: WZB9127XOA)
    Fd&c yellow no. 6 ( UNII: H77VEI93A8)
    Cellulose, microcrystalline ( UNII: OP1R32D61U)
    Polyethylene glycol ( UNII: 3WJQ0SDW1A)
    Polyvinyl alcohol ( UNII: 532B59J990)
    Stearic acid ( UNII: 4ELV7Z65AP)
    Talc ( UNII: 7SEV7J4R1U)
    Titanium dioxide ( UNII: 15FIX9V2JP)

    Product Characteristics

    Color ORANGE Size 14 mm
    Shape CAPSULE Score 1
    Imprint Code I2

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    ANDA ANDA077349 USA

    Labeler - HyVee Inc( 006925671)

    Principal display panel

    See New Warnings Information

    Compare to Motrin® IB active ingredient

    Ibuprofen IB

    Ibuprofen Tablets, 200 mg

    Pain Reliever Fever Reducer (NSAID)

    **CAPSULE-SHAPED TABLETS

    Actual Size

    Ibuprofen IB Carton Image 1 Ibuprofen IB Carton Image 1

    Ibuprofen IB Carton Image 2