Sucralfate (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer

The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach.

Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.

Maintenance Therapy

The recommended adult oral dosage is 1 g twice a day.

Elderly

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS , Geriatric Use).

Call your doctor for medical advice about side effects. You may report side effects to TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HOW SUPPLIED

Product: 63739-943

NDC: 63739-943-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Sucralfate

Label Image
(click image for full-size original)
SUCRALFATE
sucralfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-943(NDC:0093-2210)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCRALFATE (SUCRALFATE) SUCRALFATE 1 g
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 19mm
Flavor Imprint Code TEVA;22;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-943-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-943-10)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070848 11/11/1996
Labeler — McKesson Corporation (140529962)
Establishment
Name Address ID/FEI Operations
McKesson Corporation 140529962 REPACK (63739-943)

Revised: 03/2018 McKesson Corporation

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