Ibuprofen: Package Insert and Label Information

IBUPROFEN- ibuprofen tablet
Contract Pharmacy Services-PA

DRUG FACTS

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:
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever

WARNINGS

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

• right before or after heart surgery

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

Ask a doctor before use if you are

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

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
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • adults and children 12 years and older

    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

    children under 12 years ask a doctor

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)

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original–08/2010–NJW

Package Label

Blister of 30 Tablets
(click image for full-size original)

Blister of 30 Tablets

IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-303(NDC:0904-7915)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-303-30 30 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072096 08/02/2010
Labeler — Contract Pharmacy Services-PA (945429777)

Revised: 07/2010 Contract Pharmacy Services-PA

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