Mediclarum
Medicine guide

Hyoscyamine Sulfate Tab

.125 mg · Tablet

  • Prescription only
Active substance
Hyoscyamine Sulfate
Made by
Northwind Health Company, LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-01

Used for
  • This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis.
The label’s usual adult dose

Adults and adolescents 12 years of age and older:: 1 to 2 tablets orally three or four times a day, thirty minutes to one hour before meals and at bedtime.

Do not exceed 12 tablets in 24 hours.

Full directions ↓
Do not take it if

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,…

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
43other products contain Hyoscyamine Sulfate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.

From the official label · 2026-01-01 · DailyMed

How it works

From this product’s own US prescribing label.

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.

How it leaves the 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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-01

Do not take it if

  • 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.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 orally 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.

Quoted from the official label, section “Dosage & Administration”.

Other 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.
  • 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.
  • Information for Patients:
  • Drug Interactions:
  • Pregnancy: Pregnancy Category C.
  • Nursing Mothers: This product is excreted in human milk.
  • Pediatric Use:
  • Geriatric Use:

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Pregnancy Category C.
  • 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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 LD 50 for hyoscyamine is 375 mg/kg.
  • Hyoscyamine is dialyzable.

Quoted from the official label, section “Overdosage”.

Use in children

  • 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • 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.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Hyoscyamine Sulfate TAB is supplied as round, green, peppermint flavored tablets with "40" debossed on one side.They are available in bottles of 30 tablets, NDC 51655-845-52.
  • Storage and Handling 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 .
  • All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
  • Please NOTE:
  • This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.
  • No representation is made as to generic status or bioequivalency.
  • Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.
  • Distributed by:
  • Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 L-0402 Rev. 0723-01 0S42192340

Quoted from the official label, section “How Supplied”.

How to store it

  • 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 .

Quoted from the official label, section “Storage and Handling”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

  • Inactive ingredients include:
  • Green LKB #LB-620, lactose monohydrate, magnesium stearate (veg), mannitol USP, peppermint flavor, starch and stearic acid.

Quoted from the official label, section “Inactive Ingredients”.

What is in it

  • Each round, green, peppermint flavored tablet, for oral administration contains:
  • Hyoscyamine Sulfate, USP …… 0.125 mg. Hyoscyamine sulfate is one of the principal anticholinergic/ antispasmodic components of belladonna alkaloids. (C 17 H 23 NO 3 ) 2
  • H 2 SO 4
  • 2H 2 O M.W. = 712.85 Hyoscyamine Sulfate

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Sugar alcoholsmannitol USPSorbitol and similar can upset the stomach and matter with fructose intolerance.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (34)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Showing 34 of 34

Details

Made byNorthwind Health Company, LLC
Active substanceHyoscyamine Sulfate
Strength.125 mg
FormTablet
RouteOral
Packs30 TABLET in 1 BOTTLE, PLASTIC
NDC51655-845

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Hyoscyamine Er.375 mgPrescription onlyTablet, Extended Release Mylan Pharmaceuticals Inc. · Hyoscyamine SulfateHyoscyamine Sulfate.125 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Hyoscyamine SulfateHyoscyamine Sulfate.375 mgPrescription onlyTablet, Extended Release Laser Pharmaceuticals, LLC · Hyoscyamine SulfateHyoscyamine Sulfate.125 mgPrescription onlyTablet, Orally Disintegrating Patrin Pharma, Inc. · Hyoscyamine SulfateHyoscyamine Sulfate.125 mgPrescription onlyTablet Patrin Pharma, Inc. · Hyoscyamine SulfateHyoscyamine Sulfate.375 mgPrescription onlyTablet, Extended Release Patrin Pharma, Inc. · Hyoscyamine Sulfate

See every product with Hyoscyamine Sulfate