Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension should be administered 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 Oral Suspension.
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.
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 VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Sucralfate Oral Suspension, 1 g/10 mL is a pink suspension supplied as follows:
NDC 66689-790-01: 10 mL unit-dose cup
NDC 66689-790-30: Case contains 30 unit-dose cups of 10 mL
(NDC 66689-790-01), packaged in 3 trays of 10 unit-dose cups each.
NDC 66689-790-40: Case contains 40 unit-dose cups of 10 mL
(NDC 66689-790-01), packaged in 4 trays of 10 unit-dose cups each.
NDC 66689-790-50: Case contains 50 unit-dose cups of 10 mL
(NDC 66689-790-01), packaged in 5 trays of 10 unit-dose cups each.
NDC 66689-790-99: Case contains 100 unit-dose cups of 10 mL
(NDC 66689-790-01), packaged in 10 trays of 10 unit-dose cups each.
SHAKE WELL BEFORE USING. AVOID FREEZING.
Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Largo, FL 33771, USA
Sucralfate Oral Suspension
1 g / 10 mL
Delivers 10 mL
Store at 20°–25°C (68°– 77°F)
Largo, FL 33771, USA
|SUCRALFATE sucralfate suspension|
|Labeler — VistaPharm, Inc. (116743084)|
Revised: 09/2022 VistaPharm, Inc.
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