Hyoscyamine Sulfate
Tablet · Oral, Sublingual, Subcutaneous
Uses
Hyoscyamine Sulfate 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 Tablets, USP 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 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:1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
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.
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.
Precautions
PRECAUTIONS General Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension and renal disease. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis. Information for patients 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. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution. 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 Tablets before meals; antacids after meals. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animal have been perfomed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem. Pregnancy Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can causae fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine Sulfate Tablets given to a pregnant woman only if clearly needed. Nursing Mothers Hyoscyamine sulfate is excreted in human milk. Caution should be excercised when Hyoscyamine sulfate Tablets are administered to a nursing woman. Geriatric use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patient are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Side effects
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 SUSPECTED ADVERSE REACTIONS, contact Granulation Technology, Inc. at 1-973-276-0740 or FDA’s toll free number at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Tablets before meals; antacids after meals.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can causae fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine Sulfate Tablets given to a pregnant woman only if clearly needed.
Geriatric use
Geriatric use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patient are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Overdosage
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing amd CNS stimulation. Measures to be taken are immediately lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect of paralysis of respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.
Description
Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2
• H 2 SO 4
• 2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: Each tablet also contains inactive ingredients: crospovidone, microcrystalline cellulose, magnesium stearate, mannitol and colloidal silicon dioxide. Structure
How supplied
Hyoscyamine Sulfate Tablets, 0.125 mg are white to off-white, round, convex tablets,debossed "G 17" on one side and plain on the other side. NDC 63561- 0203 -01: Bottle of 100 Tablets Store at controlled room temperature 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C (59° to 86°F). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Manufactured by: Granulation Technology, Inc. Fairfield, NJ 07004, USA OS0023 Rev 07/26
Patient information
Information for patients 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. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.
Label text from the FDA structured product label by Granulation Technology, Inc. (revised Jul 29, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hyoscyamine Sulfate in 31 products
Hyoscyamine Sulfate NDC products (31)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 62559-424 | Hyoscyamine Sulfate .125 mg/1 Tablet | ANI Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 62559-423 | Hyoscyamine Sulfate .375 mg/1 Tablet, Extended Release | ANI Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 62559-422 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | ANI Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 62559-421 | Hyoscyamine Sulfate .125 mg/1 Tablet | ANI Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 54288-111 | Hyoscyamine Sulfate .5 mg/mL Injection, Solution | BPI Labs LLC | UNAPPROVED DRUG OTHER |
| 72162-1941 | Hyoscyamine Sulfate .125 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 72162-1940 | Hyoscyamine Sulfate .125 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 72162-1939 | Hyoscyamine Sulfate .125 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 71335-1647 | Hyoscyamine Sulfate .125 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 62135-511 | Hyoscyamine Sulfate .125 mg/5mL Elixir | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 62135-860 | Hyoscyamine Sulfate .375 mg/1 Tablet, Extended Release | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 62135-858 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 62135-513 | Hyoscyamine Sulfate .125 mg/mL Solution | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 62135-512 | Hyoscyamine Sulfate .125 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER |
| 63561-0202 | Hyoscyamine Sulfate .125 mg/1 Tablet | Granulation Technology, Inc. | UNAPPROVED DRUG OTHER |
| 63561-0203 | Hyoscyamine Sulfate .125 mg/1 Tablet | Granulation Technology, Inc. | UNAPPROVED DRUG OTHER |
| 63561-0197 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | Granulation Technology, Inc. | UNAPPROVED DRUG OTHER |
| 16477-738 | Hyoscyamine Sulfate .375 mg/1 Tablet, Extended Release | Laser Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 0615-8554 | Hyoscyamine Sulfate .125 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | UNAPPROVED DRUG OTHER |
| 0615-8537 | Hyoscyamine Sulfate .125 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | UNAPPROVED DRUG OTHER |
| 51655-764 | Hyoscyamine Sulfate .125 mg/1 Tablet | Northwind Health Company, LLC | UNAPPROVED DRUG OTHER |
| 39328-052 | Hyoscyamine Sulfate .375 mg/1 Tablet, Extended Release | Patrin Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 39328-051 | Hyoscyamine Sulfate .125 mg/1 Tablet | Patrin Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 39328-050 | Hyoscyamine Sulfate .125 mg/1 Tablet | Patrin Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 39328-049 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | Patrin Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 72789-563 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | PD-Rx Pharmaceuticals, Inc. | UNAPPROVED DRUG OTHER |
| 82804-965 | Hyoscyamine Sulfate .125 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER |
| 70518-4436 | Hyoscyamine Sulfate .125 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER |
| 69367-677 | Hyoscyamine Sulfate .125 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-678 | Hyoscyamine Sulfate .125 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-679 | Hyoscyamine Sulfate .125 mg/1 Tablet, Orally Disintegrating | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Hyoscyamine Sulfate used for?
Hyoscyamine Sulfate 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…
What are the side effects of Hyoscyamine Sulfate?
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;… See the full label for the complete list.
Who makes Hyoscyamine Sulfate?
Hyoscyamine Sulfate is listed by 13 labelers in the FDA NDC directory, including ANI Pharmaceuticals, Inc., BPI Labs LLC, Bryant Ranch Prepack, Chartwell RX, LLC.