Drug Catalog - Product Detail
HYOSCYAMINE SULFATE TAB DISINT 0.125 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42192-0338-01 | ACELLA PHARMACEUTICALS | 100 | MG | TABLET |
PACKAGE FILES
Generic Name
HYOSCYAMINE SULFATE
Substance Name
HYOSCYAMINE SULFATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
Description
DESCRIPTION Each round, green, peppermint flavored, orally dispersible tablet contains: Hyoscyamine Sulfate, USP …… 0.125 mg. Hyoscyamine sulfate is one of the principal anticholinergic/ antispasmodic components of belladonna alkaloids. (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • 2H 2 O M.W. = 712.85 Hyoscyamine Sulfate
How Supplied
HOW SUPPLIED Hyoscyamine Sulfate ODT is supplied as round, green, peppermint flavored tablets with "38" debossed on one side. They are available in bottles of 100 tablets, NDC 42192-338-01. Storage and Handling Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY . All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein. Distributed by: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 07/2017 500425-06
Indications & 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the condition and severity of symptoms. May be taken with or without water. Adults and adolescents 12 years of age and older: 1 to 2 tablets can be chewed or placed on tongue for disintegration three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage may be increased to every four hours as needed. Do not exceed 12 tablets in 24 hours. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.