HENRY SCHEIN IBUPROFEN - ibuprofen tablet, film coated 
Henry Schein Inc.

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Henry Schein®
Ibuprofen

Drug Facts

Active ingredient (in each tablet)

Ibuprofen (NSAID*) 200 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

• headache
• backache
• common cold
• minor arthritis pain
• toothache
• menstrual cramps
• muscular aches

Temporarily reduces fever.

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction which may include:

• hives
• asthma (wheezing)
• rash
• blisters
• skin reddening
• facial swelling
• shock

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:

• 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

• 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 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
• 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 fain
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present in the painful area
• any new or unexpected symptoms occur

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 specifically directed to 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.

Directions

• do not use 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. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• read all product information before using
• store at 68-77°F (20-25°C)
• avoid excessive heat 40°C (above 104°F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

cellulose, corn starch, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments? 1-800-472-4346

Principal Display Panel

NDC #0404-0703-13

Henry Schein®

Ibuprofen

For temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, minor arthritis pain and for the reduction of fever.

Henry Schein

Seal Of Excellence®

Ibuprofen 200 mg

(NSAID)

250 Packets/2 Tablets

Reorder

900-4691

See new warnings information

HENRY SCHEIN IBUPROFEN  ibuprofen   tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0404-0703 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (Ibuprofen) Ibuprofen 200 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSE   LACTOSE   MAGNESIUM STEARATE   POLYDEXTROSE   POLYETHYLENE GLYCOL   POVIDONE   SILICON DIOXIDE   STARCH, CORN   STEARIC ACID   TITANIUM DIOXIDE   TRIACETIN

Product Characteristics Color white (WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 44;352 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0404-0703-99 2 TABLET In 1 PACKET None 2 0404-0703-13 500 TABLET In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075139	12/30/2008

Labeler - Henry Schein Inc. (012430880)

Revised: 03/2010Henry Schein Inc.