FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Each purple and white, biphasic, capsule shaped tablet for oral administration is specially formulated to release 0.125 mg of hyoscyamine sulfate immediately and 0.250 mg hyoscyamine sulfate over the remaining 8 to 12 hours of the dosing period.
Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.
Hyoscyamine sulfate is Benzeneacetic acid, α-(hydroxymethyl)-, 8- methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate.
(C17H23NO3)2 • H2SO4 • 2H2O M.W. 712.85
Sources
Symax Duotab Manufacturers
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Capellon Pharmaceuticals, Llc
Symax Duotab | Capellon Pharmaceuticals, Llc
Adults and children 12 years of age and older: 1 to 2 tablets every 12 hours. Dosage may be adjusted to 1 tablet every 8 hours if needed. Do not exceed 4 tablets in 24 hours.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
Tablets should be swallowed whole.
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