hyoscyamine sulfate

FDA Drug Profile — Hyoscyamine Sulfate TAB, Hyoscyamine ER, Levbid, Hyoscyamine Sulfate ODT, Levsin

hyoscyamine sulfate is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Hyoscyamine Sulfate TAB, Hyoscyamine ER, Levbid. Available dosage forms: tablet, tablet, extended release, tablet, orally disintegrating, tablet, chewable.

Drug Details

Generic Name
hyoscyamine sulfate
Brand Names
Hyoscyamine Sulfate TAB, Hyoscyamine ER, Levbid, Hyoscyamine Sulfate ODT, Levsin, Levsin SL, Hyoscyamine Sulfate SL, NuLev
Application Number
Sponsor
REMEDYREPACK INC.
NDC Codes
14
Dosage Forms
TABLET, TABLET, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING, TABLET, CHEWABLE
Routes
ORAL, SUBLINGUAL
Active Ingredients
HYOSCYAMINE SULFATE

Indications and Usage

INDICATIONS AND USAGE This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

Warnings

WARNINGS Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.