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Ibuprofen (ibuprofen - ibuprofen 200 mg oral tablet) Dailymed

  1. Human OTC
  2. Archived
  3. CVS Pharmacy

Generic: ibuprofen

Ibuprofen tablet, film coated - (ibuprofen - ibuprofen 200 mg oral tablet) image
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IMPRINT: 44 393     SHAPE: oval
    COLOR: orange

All Imprints

ibuprofen - ibuprofen 200 mg oral tablet - 44 393 oval orange

ibuprofen 200 mg oral capsule - 44 393 oval orange

  1. FDA Adverse Reactions

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Active Ingredient (in Each Orange Caplet)


Ibuprofen USP, 200 mg (NSAID)**nonsteroidal anti-inflammatory drug

Purpose


Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • backache
    • muscular aches
    • menstrual cramps
    • toothache
    • the common cold
    • headache
    • minor pain of arthritis
  • temporarily reduces fever

Warnings


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • skin reddening
  • asthma (wheezing)
  • rash
  • facial swelling
  • shock
  • bulers
  • hives

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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

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

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • take with food or milk if stomach upset occurs

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
  • you have symptoms of heart problems or stroke
    • chest pain
    • weakness in one part or side of body
    • trouble breathing
    • slurred speech
    • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area

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 (1-800-222-1222) right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: 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

Other Information

  • store between 20Âș-25ÂșC (68Âș-77ÂșF) 
  • avoid excessive heat 40ÂșC (104ÂșF)  
  • see end flap for expiration date and lot number

Inactive Ingredients


carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?


Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel


♄CVSHealthℱ

Compare to the active ingredientin Motrin¼ IB Caplets†

Coated Caplets**

NDC 59779-393-15

Ibuprofen IBUPROFEN TABLETS USP, 200 mgPain reliever, Fever reducer (NSAID)

50 COATED CAPLETS****Capsule-shaped tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTEDSAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895© 2017 CVS/pharmacyCVS.comŸ 1-800-SHOP CVS V-11112

50844REV1116A39315

†This product is not manufactured or distributed by Johnson & JohnsonCorporation, owner of the registered trademark Motrin¼ IB Caplets. CVS 44-393

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