Sucralfate: Package Insert and Label Information (Page 2 of 2)

OVERDOSAGE

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity 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 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

NDC: 63629-1307-1: 100 Tablets in a BOTTLE

NDC: 63629-1307-2: 60 Tablets in a BOTTLE

NDC: 63629-1307-3: 30 Tablets in a BOTTLE

NDC: 63629-1307-4: 20 Tablets in a BOTTLE

NDC: 63629-1307-6: 150 Tablets in a BOTTLE

NDC: 63629-1307-7: 90 Tablets in a BOTTLE

NDC: 63629-1307-8: 40 Tablets in a BOTTLE

NDC: 63629-1307-9: 120 Tablets in a BOTTLE

NDC: 63629-1307-0: 28 Tablets in a BOTTLE

Sucralfate 1gm Tablet

SUCRALFATE sucralfate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1307(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:63629-1307-1 100 TABLET in 1 BOTTLE None 2 NDC:63629-1307-2 60 TABLET in 1 BOTTLE None 3 NDC:63629-1307-3 30 TABLET in 1 BOTTLE None 4 NDC:63629-1307-4 20 TABLET in 1 BOTTLE None 5 NDC:63629-1307-6 150 TABLET in 1 BOTTLE None 6 NDC:63629-1307-7 90 TABLET in 1 BOTTLE None 7 NDC:63629-1307-8 40 TABLET in 1 BOTTLE None 8 NDC:63629-1307-9 120 TABLET in 1 BOTTLE None 9 NDC:63629-1307-0 28 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070848 11/11/1996

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	repack (63629-1307), relabel (63629-1307)

Revised: 05/2023 Bryant Ranch Prepack