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...
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.
Rx Only
Each tablet for sublingual administration contains:
| Hyoscyamine Sulfate | 0.125 mg |
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.
Inactive ingredients include: green dye, lactose monohydrate, magnesium stearate (veg.), mannitol, peppermint flavor, starch, and stearic acid.
Hyoscyamine has actions similar to those of atropine, but is more potent in both its central and peripheral effects. This product inhibits gastrointestinal propulsive motility and decreases gastric acid secretions. This product controls excessive pharyngeal, tracheal, and bronchial secretion. Once absorbed, this product disperses rapidly in the blood and is distributed throughout the entire body. The majority of hyoscyamine sulfate is excreted in the urine unchanged within the first 12 hours and only traces of hyoscyamine sulfate are found in the breast milk.
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.
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.
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.
Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate.
Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.
This medication should be taken 30 minutes to one hour before meals.
This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke.
Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness.
Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying.
Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.
This product is excreted in human milk. This product should not be administered to a nursing mother.
This product is not recommended for use in children under twelve years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications' suppression of sweat gland activity.
A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.
Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.
Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma.
Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions.
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.
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 and CNS stimulation. Measures to be taken are immediate 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 to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.
In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable.
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.
Hyoscyamine Sulfate Sublingual Tablets are supplied as round, green, peppermint flavored tablets debossed "201" on one side. Available in bottles of 100 tablets, NDC 57629-201-10.
Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure. Store at controlled room temperature between 20°- 25°C (68° - 77°F), see USP Controlled Room Temperature.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Distributed by:
KMR Pharmaceuticals LLC
New York, NY 10022
NDC 57629-201-10
Hyoscyamine
Sulfate
Sublingual Tablets
Each sublingual tablet contains:
Hyoscyamine Sulfate 0.125 mg
Rx Only
100 Tablets
KMR Pharmaceuticals LLC
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57629-201-10 | 2025-04-28 | C162847 | 48780-1 | 9d75b9d0-79ae-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Sublingual Tablets |
| 57629-201-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-79ae-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Sublingual Tablets |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57629-201-10 | EA - Each | 57629-201 | 808eaa58-ac96-42e4-9a50-74f47b0e6d3a | 1 | 2015-10-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Hyoscyamine Sulfate | ACTIVE INGREDIENT | F2R8V82B84 | 1 | |
| Hyoscyamine | ACTIVE MOIETY | PX44XO846X | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57629-201 | 57629-201-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Hyoscyamine Sulfate | F2R8V82B84 | ACTIB |
| lactose monohydrate | EWQ57Q8I5X | IACT |
| mannitol | 3OWL53L36A | IACT |
| stearic acid | 4ELV7Z65AP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / TOPICAL | 4 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, ORALLY DISINTEGRATING / ORAL | 366 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, DELAYED RELEASE / ORAL | 2043 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15400 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 980.4 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | 180 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION / OPHTHALMIC | 9 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBCUTANEOUS | 99 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 9.5 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION/ DROPS / OPHTHALMIC | 4.6 %w/v | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER / RESPIRATORY (INHALATION) | 6 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE / ORAL | 1562 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, EXTENDED RELEASE / ORAL | 160 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 181 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, COATED / ORAL | 177.7 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 616 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION / INTRAVENOUS | 15200 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 113 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 107 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / ORAL | 4364 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, FILM COATED / ORAL | 2309 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | GRANULE / ORAL | 1328 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 4.35 %w/w | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INHALANT / ORAL | NA | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 520 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| lactose monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3378a877-b315-304f-e063-6294a90a90bc | faef5e1a-bdd0-4de7-9cef-bb50418f3084 | 2025-04-23 | Warnings, Adverse reactions | faef5e1a-bdd0-4de7-9cef-bb50418f3084 |
Adverse event summaries are temporarily unavailable. Other product information remains available.