Hyoscyamine Sulfate Sublingual .125 mg/1
Hyoscyamine Sulfate Sublingual · TABLET · Direct_Rx
Hyoscyamine sulfate is an anticholinergic medication placed under the tongue to relieve muscle spasms and cramping in the stomach and intestines. It is commonly used to treat symptoms of irritable bowel syndrome and other gastrointestinal conditions.
Key Facts
- Brand Name
- Hyoscyamine Sulfate Sublingual
- Generic Name
- Hyoscyamine Sulfate Sublingual
- NDC Code (Product)
72189-666- Manufacturer
- Direct_Rx
- Strength
- .125 mg/1
- Dosage Form
- TABLET
- Route
- SUBLINGUAL
- Marketing Status
- Marketing Start
- 03/11/2026
Recall History
Virtus Pharmaceuticals, Llc
Chemical Contamination: Bottles may contain broken dessicants
VIRTUS PHARMACEUTICALS OPCO II L
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 sublingually 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
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.
Frequently Asked Questions
What is Hyoscyamine Sulfate Sublingual used for?
Hyoscyamine sulfate is an anticholinergic medication placed under the tongue to relieve muscle spasms and cramping in the stomach and intestines. It is commonly used to treat symptoms of irritable bowel syndrome and other gastrointestinal conditions.
Is Hyoscyamine Sulfate Sublingual a controlled substance?
Hyoscyamine Sulfate Sublingual is not classified as a controlled substance by the DEA.
What is the generic name for Hyoscyamine Sulfate Sublingual?
The generic name for Hyoscyamine Sulfate Sublingual is Hyoscyamine Sulfate Sublingual. There are no other listed brand versions of Hyoscyamine Sulfate Sublingual.
What is the NDC code for Hyoscyamine Sulfate Sublingual .125 mg/1?
The NDC (National Drug Code) for Hyoscyamine Sulfate Sublingual .125 mg/1 is 72189-666, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)