Hyoscyamine Sulfate ODT .125 mg/1

Hyoscyamine Sulfate · TABLET, ORALLY DISINTEGRATING · Westminster Pharmaceuticals, LLC

1 Recall on Record

Plain English

Hyoscyamine Sulfate ODT is a tablet, orally disintegrating containing hyoscyamine sulfate at .125 mg/1, taken oral. Manufactured by Westminster Pharmaceuticals, LLC.

Key Facts

Brand Name: Hyoscyamine Sulfate ODT
Generic Name: Hyoscyamine Sulfate
NDC Code (Product): 69367-679
Manufacturer: Westminster Pharmaceuticals, LLC
Strength: .125 mg/1
Dosage Form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Marketing Status
Marketing Start: 04/02/2025

Recall History

1 Recall on Record

Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea161 reports

diarrhoea141 reports

headache138 reports

pain133 reports

fatigue132 reports

dizziness125 reports

product dose omission issue90 reports

drug ineffective89 reports

dyspnoea89 reports

vomiting87 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Orally Disintegrating Tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a "drying agent" in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase a…

Dosage & Administration

DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the conditions and severity of symptoms. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

Warnings

WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

Contraindications

CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Drug Interactions

Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Adverse Reactions

ADVERSE REACTIONS The following adverse reactions have been reported for hyoscyamine sulfate and 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; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; abdominal pain; diarrhea; 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); short-term memory loss; hallucinations; and decreased sweating. To report an adverse reaction, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Hyoscyamine Sulfate ODT used for?

Hyoscyamine Sulfate ODT contains Hyoscyamine Sulfate. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.

Is Hyoscyamine Sulfate ODT a controlled substance?

Hyoscyamine Sulfate ODT is not classified as a controlled substance by the DEA.

What is the generic name for Hyoscyamine Sulfate ODT?

The generic name for Hyoscyamine Sulfate ODT is Hyoscyamine Sulfate. There are 12 other brand versions of Hyoscyamine Sulfate.

What is the NDC code for Hyoscyamine Sulfate ODT .125 mg/1?

The NDC (National Drug Code) for Hyoscyamine Sulfate ODT .125 mg/1 is 69367-679, listed by Westminster Pharmaceuticals, LLC.

Product NDC

69367-679

Package NDC

69367-679-01

Other Hyoscyamine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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