Label: CARAFATE- sucralfate 1gm tablet
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- NDC Code(s): 80425-0091-1
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0093-2210
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 16, 2020
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Dosage and Administration Section
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.
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Indications and Usage Section
INDICATIONS AND USAGE
Sucralfate tablets, USP are indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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 for duodenal ulcer patients at reduced dosage after healing of acute ulcers. - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CARAFATE
sucralfate 1gm tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0091(NDC:0093-2210) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUCRALFATE (UNII: XX73205DH5) (SUCRALFATE - UNII:XX73205DH5) SUCRALFATE 1 g Product Characteristics Color white Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code TEVA;22;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0091-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/11/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070848 11/11/1996 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0091)
