Hyoscyamine Sulfate SL .125 mg/1
Hyoscyamine Sulfate · TABLET · Westminster Pharmaceuticals, LLC
Hyoscyamine Sulfate SL is a tablet containing hyoscyamine sulfate at .125 mg/1, taken oral. Manufactured by Westminster Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Hyoscyamine Sulfate SL
- Generic Name
- Hyoscyamine Sulfate
- NDC Code (Product)
69367-678- Manufacturer
- Westminster Pharmaceuticals, LLC
- Strength
- .125 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Marketing Start
- 04/02/2025
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.
Aidapak Services, LLC
Labeling: Label Mixup: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: AD21790_13, EXP: 5/1/2014; CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD46265_4, EXP: 5/15/2014; guanFACINE HCl, Tablet, 2 mg, NDC 65162071310, Pedigree: W003678, EXP: 6/25/2014; guanFACIN
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hyoscyamine Sulfate Sublingual 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 Sublingual 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 agents.
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 SL used for?
Hyoscyamine Sulfate SL contains Hyoscyamine Sulfate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Hyoscyamine Sulfate SL a controlled substance?
Hyoscyamine Sulfate SL is not classified as a controlled substance by the DEA.
What is the generic name for Hyoscyamine Sulfate SL?
The generic name for Hyoscyamine Sulfate SL is Hyoscyamine Sulfate. There are 12 other brand versions of Hyoscyamine Sulfate.
What is the NDC code for Hyoscyamine Sulfate SL .125 mg/1?
The NDC (National Drug Code) for Hyoscyamine Sulfate SL .125 mg/1 is 69367-678, listed by Westminster Pharmaceuticals, LLC.
Other Hyoscyamine Brands
See all →- Hyoscyamine Sulfate Sublingual.125 mg/172189-666
- Hyoscyamine Sulfate.125 mg/10615-8537
- Hyoscyamine Sulfate.125 mg/10615-8554
- Hyoscyamine Sulfate.125 mg/139328-049
- Hyoscyamine Sulfate.375 mg/139328-052
- Hyoscyamine Sulfate TAB.125 mg/142708-183
- Hyoscyamine Sulfate.125 mg/151655-764
- Hyoscyamine Sulfate.125 mg/5mL62135-511
- Hyoscyamine Sulfate.125 mg/162559-424
- Hyoscyamine Sulfate.125 mg/163629-1030
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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