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HYOSCYAMINE SULFATE TABS 0.125 MG 100 - .125 mg/1 TABLET
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HYOSCYAMINE SULFATE TABS 0.125 MG 100

Generic: hyoscyamine sulfate

HYOSCYAMINE SULFATE TABS 0.125 MG 100

NDC:42192-0340-01
Manufacturer:Acella Pharmaceuticals, LLC
Strength:.125 mg/1
Dosage Form:TABLET
Route:ORAL

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Drug Information

Identification

Generic Name

hyoscyamine sulfate

Brand Name

Hyoscyamine Sulfate TAB

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

TABLET

Route of Administration

ORAL

Active Ingredients

IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

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.

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.

Dosage & 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 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.

Adverse Reactions

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.

Information for Patients

Information for Patients: This medication should be taken 30 minutes to one hour before meals. This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke. Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.