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Henry Schein Ibuprofen

Dosage form: tablet, film coated
Ingredients: Ibuprofen 200mg
Labeler: Henry Schein Inc.
NDC Code: 0404-0703

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, especially in people allergic to aspirin. Symptoms 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
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 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 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 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.

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

corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetate, 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

HENRY SCHEIN IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0703
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
SILICON DIOXIDE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code44;352
Contains    
Packaging
#Item CodePackage Description
1NDC:0404-0703-992 TABLET, FILM COATED in 1 PACKET
2NDC:0404-0703-13250 TABLET, FILM COATED in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513912/30/2008
Labeler - Henry Schein Inc. (012430880)

Revised: 10/2012
 
Henry Schein Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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