Prescription Drug Information: Sucralfate (Page 2 of 2)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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].

Rx Only

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

VP1059R10

02/2020

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

Sucralfate Oral Suspension

1 g / 10 mL

Shake Well

Delivers 10 mL

Store at 20°–25°C (68°– 77°F)

Rx Only

VP1060R6

01/18

XACTDOSE

Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

NDC 66689-790-01

Lidding label
(click image for full-size original)
SUCRALFATE sucralfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-790(NDC:58914-170)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUCRALFATE (SUCRALFATE) SUCRALFATE 1 g in 10 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
METHYLPARABEN
SORBITOL
WATER
FD&C RED NO. 40
Product Characteristics
Color pink Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66689-790-30 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-30) and contains a CUP, UNIT-DOSE (66689-790-01)
1 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-30)
2 NDC:66689-790-40 4 TRAY in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-40) and contains a CUP, UNIT-DOSE (66689-790-01)
2 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-40)
3 NDC:66689-790-50 5 TRAY in 1 CASE contains a TRAY
3 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-50) and contains a CUP, UNIT-DOSE (66689-790-01)
3 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-50)
4 NDC:66689-790-99 10 TRAY in 1 CASE contains a TRAY
4 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (66689-790-99) and contains a CUP, UNIT-DOSE (66689-790-01)
4 NDC:66689-790-01 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (66689-790-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019183 08/16/2012
Labeler — VistaPharm, Inc. (116743084)

Revised: 09/2022 VistaPharm, Inc.

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