Drug Facts
Composition & Profile
Identifiers & Packaging
Hyoscyamine Sulfate TAB is supplied as round, green, peppermint flavored tablets with "40" debossed on one side. They are available in NDC: 70518-3847-00 NDC: 70518-3847-01 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 180 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: Hyoscyamine Sulfate TAB GENERIC: hyoscyamine sulfate DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-3847-0 NDC: 70518-3847-1 COLOR: green FLAVOR: PEPPERMINT SHAPE: ROUND SCORE: No score SIZE: 6 mm IMPRINT: 40 PACKAGING: 90 in 1 BOTTLE, PLASTIC PACKAGING: 180 in 1 BOTTLE, PLASTIC ACTIVE INGREDIENT(S): HYOSCYAMINE SULFATE 0.125mg in 1 INACTIVE INGREDIENT(S): D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARIC ACID MM2
- Hyoscyamine Sulfate TAB is supplied as round, green, peppermint flavored tablets with "40" debossed on one side. They are available in NDC: 70518-3847-00 NDC: 70518-3847-01 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 180 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
- DRUG: Hyoscyamine Sulfate TAB GENERIC: hyoscyamine sulfate DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-3847-0 NDC: 70518-3847-1 COLOR: green FLAVOR: PEPPERMINT SHAPE: ROUND SCORE: No score SIZE: 6 mm IMPRINT: 40 PACKAGING: 90 in 1 BOTTLE, PLASTIC PACKAGING: 180 in 1 BOTTLE, PLASTIC ACTIVE INGREDIENT(S): HYOSCYAMINE SULFATE 0.125mg in 1 INACTIVE INGREDIENT(S): D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL STARCH, CORN STEARIC ACID MM2
Overview
Each round, green, peppermint flavored tablet, for oral administration 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
Indications & 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 & 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 orally 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.
Warnings & Precautions
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.
Contraindications
Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.
Adverse Reactions
Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic/ antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); and decreased sweating.
Drug Interactions
Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.
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