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Hyoscyamine

Hyoscyamine is an anticholinergic (antispasmodic) medicine used as add-on treatment for stomach and bowel conditions such as peptic ulcer and irritable bowel syndrome, bladder spasm problems, and certain other uses depending on the product.

Brand names CystospazED-SpazHyomaxHyophenHyosyne +11 more
Rx Forms 7
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 56 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026
Hyoscyamine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Hyoscyamine is an older antispasmodic, on the U.S. market since the 1950s and available generically, that blocks acetylcholine (a nerve signal) to relax gut and bladder spasms and slow secretions. It is mostly used as an add-on for irritable bowel syndrome, peptic ulcer or bladder spasm. Most people manage it, but the drying effects show up: dry mouth, blurred vision, constipation and some drowsiness. Watch for overheating, since it cuts sweating and heat stroke is a real risk in hot weather, and call your prescriber about new confusion or agitation. It is not safe with glaucoma, myasthenia gravis, or a blockage of the bladder outlet or bowel.

Clinical pearls

  • If you also use antacids, take hyoscyamine before meals and the antacid after, because antacids reduce how much hyoscyamine you absorb.
  • Tricyclic antidepressants, amantadine, haloperidol, MAO inhibitors and some antihistamines all add to its drying and sedating effects.
  • Older adults feel it more strongly, so watch closely for dizziness, confusion or trouble urinating.
  • With an ileostomy or colostomy, new diarrhea can be an early sign of a partial bowel blockage, so report it.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Oral solution, Sublingual tablet +4
Earliest FDA record1955
Companies listing it with the FDA23
FDA label last updatedJul 15, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Hyoscyamine, written from its FDA label.

What Hyoscyamine is used for

▾

Hyoscyamine is used as add-on treatment for many stomach, bowel and bladder problems. Uses vary by product.

  • Peptic ulcer (add-on therapy)
  • Irritable bowel syndrome and other functional gastrointestinal disorders
  • Spastic colitis, spastic bladder, cystitis, pylorospasm and abdominal cramps
  • Mild dysenteries, diverticulitis and acute enterocolitis
  • Neurogenic bladder and neurogenic bowel disturbances
  • Biliary and renal colic, along with morphine or other narcotics or analgesics
  • Acute rhinitis, as a “drying agent”
  • Parkinsonism, to reduce rigidity, tremors, drooling and excess sweating (several tablet products)
  • Poisoning by anticholinesterase agents (several products, including the injection)
  • Infant colic (elixir and drops, including Hyosyne and Levsin)
  • Hyoscyamine Sulfate Injection: reducing gut motility for endoscopy, pain in pancreatitis, certain cases of partial heart block, and use before anesthesia

How Hyoscyamine works

▾

Hyoscyamine blocks the action of acetylcholine, a chemical messenger, at nerve receptors in smooth muscle, the heart and glands. This slows gut movement, lowers stomach acid and reduces secretions, which helps ease spasm and cramping.

Hyoscyamine dosage

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How it is taken depends on the product. Many tablet labels call for dosing 30 to 60 minutes before meals and at bedtime, repeated every few hours as needed, with a daily limit. Dissolving, chewable and under-the-tongue tablets can be taken with or without water.

  • Oral drops need careful measuring, and dosing for young children is by weight.
  • The injection is given by a healthcare professional.
  • Extended-release tablets release the drug over 12 hours.

Follow your prescriber and product label.

Dosing details from the FDA-approved label

From the Hyoscyamine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Oral drops (solution): adults and pediatric patients 12 years of age and older
    • 1 to 2 mL every four hours or as needed
    • Maximum: Do not exceed 12 mL in 24 hours
    • Dosage may be adjusted according to the conditions and severity of symptoms; measure dosage very carefully
  • Oral drops (solution): pediatric patients 2 to under 12 years of age
    • 1/4 to 1 mL every four hours or as needed
    • Maximum: Do not exceed 6 mL in 24 hours
    • Measure dosage very carefully
  • Oral drops (solution): pediatric patients under 2 years of age
    • Based on body weight, may be repeated every four hours or as needed: 3.4 kg (7.5 lb.) 4 drops
    • 5 kg (11 lb.) 5 drops
    • 7 kg (15 lb.) 6 drops
    • 10 kg (22 lb.) 8 drops
    • Maximum: In 24 hours: 24 drops (3.4 kg); 30 drops (5 kg); 36 drops (7 kg); 48 drops (10 kg)
    • Dose based on body weight; use a dropper marked 3, 4, 5 DROPS and 0.25 mL
  • Elixir: adults and pediatric patients 12 years of age and older
    • 1 to 2 teaspoonfuls every four hours or as needed
    • Maximum: Do not exceed 12 teaspoonfuls in 24 hours
    • Measure dosage very carefully
  • Elixir: pediatric patients 2 to under 12 years of age
    • Based on body weight, may be repeated every four hours or as needed: 10 kg (22 lb.) 1/4 teaspoon (1.25 mL)
    • 20 kg (44 lb.) 1/2 teaspoonful (2.5 mL)
    • 40 kg (88 lb.) 3/4 teaspoonful (3.75 mL)
    • 50 kg (110 lb.) 1 teaspoonful (5 mL)
    • Maximum: Do not exceed 6 teaspoonfuls in 24 hours
    • Dose based on body weight
  • Tablets (oral, sublingual, orally disintegrating, chewable) 0.125 mg: adults and pediatric patients 12 years of age and older
    • 1 to 2 tablets every four hours or as needed
    • Maximum: Do not exceed 12 tablets in 24 hours
    • Some labels: take 30 to 60 minutes before meals and at bedtime; geriatric patients may be more sensitive to the usual adult dose
  • Tablets (oral, sublingual, orally disintegrating, chewable) 0.125 mg: pediatric patients 2 to under 12 years of age
    • 1/2 to 1 tablet every four hours or as needed
    • Maximum: Do not exceed 6 tablets in 24 hours
  • Injection: gastrointestinal disorders (adults)
    • 0.5 to 1 mL (0.25 to 0.5 mg) subcutaneously, intramuscularly, or intravenously
    • Some patients need a single dose, others two, three, or four times a day at four hour intervals
  • Injection: diagnostic procedures (adults)
    • 0.5 to 1 mL (0.25 to 0.5 mg) administered intravenously 5 to 10 minutes prior to the diagnostic procedure
  • Injection: anesthesia, adults and pediatric patients over 2 years of age
    • Pre-anesthetic: 5 µg (0.005 mg) per kg of body weight, given thirty to sixty minutes prior to induction of anesthesia
    • During surgery for drug-induced bradycardia, intravenously in increments of 0.25 mL, repeated as needed
    • Reversal of neuromuscular blockade: 0.2 mg (0.4 mL) for every 1 mg neostigmine or equivalent dose of physostigmine or pyridostigmine
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Hyoscyamine Sulfate Oral Drops (Hyoscyamine Sulfate Oral Solution, USP) Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully. Adults and pediatric patients 12 years of age and older : 1 to 2 mL every four hours or as needed. Do not exceed 12 mL in 24 hours. Pediatric patients 2 to under 12 years of age : 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours. Pediatric patients under 2 years of age : The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed. Body Weight Usual Dose Do Not Exceed In 24 Hours 3.4 kg (7.5 lb.) 4 drops 24 drops 5 kg (11 lb.) 5 drops 30 drops 7 kg (15 lb.) 6 drops 36 drops 10 kg (22 lb.) 8 drops 48 drops Use a dropper having markings of 3, 4, 5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows: Approximate Equivalent Amount Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL) Hyoscyamine Sulfate (mg) 3 DROPS 0.08 mL 0.01 mg 4 DROPS 0.11 mL 0.01375 mg 5 DROPS 0.14 mL 0.0175 mg 0.25 mL 0.25 mL 0.03125 mg Hyoscyamine Sulfate Elixir Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully. Adults and pediatric patients 12 years of age and older : 1 to 2 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours. Pediatric patients 2 to under 12 years of age : Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6 teaspoonfuls in 24 hours. Body Weight Usual Dose 10 kg (22 lb.) 1/4 teaspoon (1.25 mL) 20 kg (44 lb.) 1/2 teaspoonful (2.5 mL) 40 kg (88 lb.) 3/4 teaspoonful (3.75 mL) 50 kg (110 lb.) 1 teaspoonful (5 mL) Hyoscyamine Sulfate Tablets, 0.125 mg Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg Dosage may be adjusted according to the conditions and severity of symptoms. The sublingual tablets may be taken sublingually, orally or chewed. 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.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Hyoscyamine side effects

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Most side effects come from the drug’s drying and muscle-relaxing effects.

Common side effects

  • Dry mouth
  • Blurred vision
  • Drowsiness or dizziness
  • Constipation
  • Difficulty starting urination or urinary retention
  • Headache
  • Nausea or vomiting
  • Decreased sweating
  • Drowsiness, dizziness or weakness
  • Constipation or bloating
  • Fast heartbeat or palpitations

When to get medical help

  • Get medical help right away if you have fever or heat stroke signs in hot weather (heat prostration from decreased sweating).
  • Call your doctor if you have confusion, hallucinations, memory loss, disorientation or unusual agitation.
  • Call your doctor if you cannot urinate.
  • Call your doctor if you develop diarrhea, especially with an ileostomy or colostomy, since it can be an early sign of a partial bowel blockage.
  • Seek help for a fast or pounding heartbeat, eye pain or hives and other allergic reactions.

Call your doctor for confusion, hallucinations, memory loss, inability to urinate, hives or signs of overheating.

Hyoscyamine warnings and precautions

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Overheating: decreased sweating can cause fever and heat stroke in hot environments.

  • It can cause drowsiness, dizziness or blurred vision, so be careful driving.
  • Psychosis and confusion have been reported in sensitive people, and symptoms usually clear in 12 to 48 hours after stopping.
  • Diarrhea can be an early sign of partial bowel blockage, especially with an ileostomy or colostomy.
  • Older adults may be more sensitive.

Hyoscyamine interactions

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Hyoscyamine can add to the effects of other drugs that block acetylcholine.

  • Other antimuscarinics, amantadine, haloperidol, phenothiazines, MAO inhibitors, tricyclic antidepressants and some antihistamines: additive effects.
  • Antacids: may reduce absorption, so take hyoscyamine before meals and antacids after.

Interactions listed in the FDA-approved label

From the Hyoscyamine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Other antimuscarinics: Additive adverse effects resulting from cholinergic blockade may occur.
  • Amantadine: Additive adverse effects resulting from cholinergic blockade may occur.
  • Haloperidol: Additive adverse effects resulting from cholinergic blockade may occur.
  • Phenothiazines: Additive adverse effects resulting from cholinergic blockade may occur.
  • Monoamine oxidase (MAO) inhibitors: Additive adverse effects resulting from cholinergic blockade may occur.
  • Tricyclic antidepressants: Additive adverse effects resulting from cholinergic blockade may occur.
  • Some antihistamines: Additive adverse effects resulting from cholinergic blockade may occur.
  • Antacids: Antacids may interfere with the absorption of hyoscyamine sulfate. Administer Hyoscyamine Sulfate Orally Disintegrating Tablets before meals, antacids after meals.
Read the label’s full interactions text

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 Orally Disintegrating Tablets before meals, antacids after meals.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿46 supplements and herbs with documented Hyoscyamine interactions, ranked by severity Check Hyoscyamine against a supplement or herb →

Before taking Hyoscyamine

▾
  • Do not use with glaucoma.
  • Do not use with obstructive uropathy such as bladder neck obstruction from prostate enlargement.
  • Do not use with gastrointestinal obstruction, paralytic ileus or intestinal atony in elderly or debilitated patients.
  • Do not use with severe ulcerative colitis or toxic megacolon.
  • Do not use with myasthenia gravis.
  • Do not use with unstable cardiovascular status in acute bleeding.
  • Older adults may be more sensitive.
  • Hyoscyamine crosses the placenta and only traces appear in breast milk, so ask your doctor.

Hyoscyamine overdose

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Overdose can cause headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dry mouth, trouble swallowing and CNS stimulation. Treatment includes stomach lavage and physostigmine, along with symptom care such as fever control. Seek emergency help right away.

What Hyoscyamine does in the body

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Hyoscyamine blocks acetylcholine in smooth muscle, heart tissue and glands. It slows movement in the gut, lowers stomach acid and reduces secretions in the throat, windpipe and bronchial tubes. At usual doses it does not act on autonomic ganglia.

How your body processes Hyoscyamine

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Hyoscyamine is absorbed well by mouth, clears quickly from the blood and spreads through the body. Its half-life is about 2 to 3½ hours. Most of it leaves in the urine unchanged within 12 hours. The extended-release tablet releases the drug over 12 hours, with peak levels around 4 hours and a longer half-life of about 7.5 hours.

How to store Hyoscyamine

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Store at controlled room temperature 20-25°C (68-77°F). Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN In case of accidental overdose, call a Poison Control Center immediately.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

46

Supplements & herbs that interact with Hyoscyamine

46 supplements and herbal products have documented interactions with Hyoscyamine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 32
  • Minor · 11
ACTIVATED CHARCOAL Major HENBANE Major SCOPOLIA Major ANGEL'S TRUMPET Moderate BACOPA Moderate BELLADONNA Moderate BETEL NUT Moderate BOXWOOD Moderate +38 more
Every supplement checked against Hyoscyamine — ranked by severity The full interaction hub: 3 major · 32 moderate · 11 minor · every one linked to its full report. Check Hyoscyamine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Hyoscyamine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Hyoscyamine — the kind of thing our pharmacy team would talk through with you at the counter.

What am I taking this for?

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Hyoscyamine calms spasms and slows secretions in the stomach, bowel and bladder. It is often an add-on for peptic ulcer or irritable bowel syndrome. Some products have additional uses, so ask me about yours.

When should I take it?

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Many tablets are taken 30 to 60 minutes before meals and at bedtime, and some are taken as needed. Follow your label, since dissolving, under-the-tongue and extended-release forms differ. If you take antacids, take them after meals.

What side effects should I expect?

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Dry mouth, blurred vision, drowsiness, dizziness and constipation are common. Use caution driving until you know how it affects you. Call your doctor if you cannot urinate or feel confused.

Is it okay to use in hot weather?

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Be careful. Hyoscyamine reduces sweating, so you can overheat and even get heat stroke. Stay cool and get help for fever or heat illness.

Can I take it with my other medicines?

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Tell me about everything you take. Antihistamines, tricyclic antidepressants, MAO inhibitors, amantadine, haloperidol and phenothiazines can add to its effects.

Who should not take it?

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People with glaucoma, certain urinary or bowel blockages, severe ulcerative colitis or myasthenia gravis should not use it. Older adults may be more sensitive.

Is Hyoscyamine available over the counter?

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No. Hyoscyamine is a prescription medicine: every Hyoscyamine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Hyoscyamine first available?

▾
The earliest FDA record we hold for Hyoscyamine is from 1955: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Hyoscyamine was first used.

Who makes Hyoscyamine?

▾
23 companies currently list Hyoscyamine products in the FDA's NDC Directory, including Bryant Ranch Prepack, Chartwell RX, LLC, ANI Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Hyoscyamine on HelloPharmacist

📊Hyoscyamine supplement interactions46 checked — ranked by severity 🌿Drug & Supplement CheckerHyoscyamine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Hyoscyamine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Hyoscyamine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Hyoscyamine forms and strengths (how it comes)

Hyoscyamine is available in 7 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Hyoscyamine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Digenyx Hyoscyamine Sulfate TAB Levsin Oscimin
How this form is used
What it may be used for
  • Digenyx is used as add-on therapy for peptic ulcer, irritable bowel syndrome and neurogenic bladder.
  • Levsin tablets are also used for infant colic (elixir and drops) and acute rhinitis.
Important instructions
  • Digenyx is taken by mouth 30 to 60 minutes before meals and at bedtime.
  • Hyoscyamine Sulfate TAB is taken by mouth, with or without water, before meals and at bedtime.
Available strengths 1 strength
0.125 mg
35 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Hyosyne
How this form is used
What it may be used for
  • Hyosyne oral drops are used as add-on therapy for peptic ulcer and irritable bowel syndrome.
  • Hyosyne elixir and drops are also used for infant colic.
Important instructions
  • Hyosyne oral drops should be measured very carefully with the supplied dropper.
  • Hyosyne dosing for children under 2 years is based on body weight.
Available strengths 2 strengths
0.125 mg/5 mL 0.125 mg/mL
16 FDA-listed product records ⓘ

Sublingual tablet

By mouth · Under the tongue
Brands Hyoscyamine Sulfate SL Hyoscyamine sulfate Sublingual Oscimin
How this form is used
What it may be used for
  • Hyoscyamine Sulfate Sublingual Tablets are used as add-on therapy for peptic ulcer and irritable bowel syndrome.
  • Hyoscyamine Sulfate Sublingual Tablets are used with narcotics for biliary and renal colic.
Important instructions
  • Hyoscyamine Sulfate SL is taken under the tongue, with or without water.
  • Hyoscyamine Sulfate SL is taken before meals and at bedtime.
Available strengths 1 strength
0.125 mg
16 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
Brands Levsin
How this form is used
What it may be used for
  • Hyoscyamine Sulfate Orally Disintegrating Tablets are used as add-on therapy for peptic ulcer and irritable bowel syndrome.
  • Hyoscyamine Sulfate Orally Disintegrating Tablets are used for parkinsonism symptoms and acute rhinitis.
Important instructions
  • Hyoscyamine Sulfate Orally Disintegrating Tablets are placed on the tongue to dissolve, with or without water.
  • Hyoscyamine Sulfate ODT is taken before meals and at bedtime, and antacids are taken after meals.
Available strengths 1 strength
0.125 mg
11 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Levbid
How this form is used
What it may be used for
  • Levbid is used as add-on therapy for peptic ulcer and irritable bowel syndrome.
  • Levbid is also used for parkinsonism symptoms and acute rhinitis.
Important instructions
  • Hyoscyamine Sulfate Extended-Release Tablets release the drug over 12 hours, and tablets may not fully break down.
Available strengths 1 strength
0.375 mg
8 FDA-listed product records ⓘ

Injection

Under the skin
Brands Levsin
How this form is used
What it may be used for
  • Hyoscyamine Sulfate Injection is used as add-on therapy for peptic ulcer and for spasm in acute episodes.
  • Hyoscyamine Sulfate Injection can reduce gut motility for procedures like endoscopy.
  • Hyoscyamine Sulfate Injection is also used before anesthesia and for pancreatitis pain, and as an antidote for anticholinesterase poisoning.
Important instructions
  • Hyoscyamine Sulfate Injection is given by a healthcare professional and is checked for particles and discoloration before use.
Available strengths 1 strength
0.5 mg/mL
3 FDA-listed product records ⓘ

Chewable tablet

By mouth
Brands NuLev
How this form is used
What it may be used for
  • NuLev is used as add-on therapy for peptic ulcer and irritable bowel syndrome.
  • NuLev is used with narcotics for biliary and renal colic.
Important instructions
  • NuLev Chewable Melt may be chewed or placed on the tongue to dissolve.
  • NuLev may be taken with or without water.
Available strengths 1 strength
0.125 mg
2 FDA-listed product records ⓘ

Hyoscyamine on the U.S. market: products, makers and brands

How Hyoscyamine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

23 companies list 54 Hyoscyamine product records with the FDA, mostly as tablet, oral solution, sublingual tablet; the earliest marketing or approval year on record is 1955. Brand names on the directory include Cystospaz, ED-Spaz, Hyomax and 13 more; the rest are generics.

7
Dose forms ⓘ
23
Labelers (makers, repackagers, distributors)
14
Brand names
54
FDA-listed product records ⓘ
1955
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack11%
Chartwell RX, LLC11%
ANI Pharmaceuticals, Inc.7%
Patrin Pharma, Inc.7%
Viatris Specialty LLC7%
Acella Pharmaceuticals, LLC6%
Other makers50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Hyoscyamine is used (Medicaid data)

A general measure of how commonly Hyoscyamine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hyoscyamine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

152,143
Medicaid prescriptions filled (Q1–Q4 2025)
$3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hyoscyamine prescribed? Of the 1,601 medications we measure, Hyoscyamine ranks #432 by Medicaid prescriptions — more than 73% of them.

Where Hyoscyamine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #432 of 1,601
#427 Tobramycin Ophthalmic 159,866 Rx #428 Nitrofurantoin 157,792 Rx #429 Glucagon Nasal Powder 154,534 Rx #430 Dextrose 153,560 Rx #431 Omalizumab Injection 153,398 Rx #432 Hyoscyamine 152,143 Rx #433 Nirmatrelvir and Riton... 151,858 Rx #434 Verapamil 151,669 Rx #435 Secukinumab Injection 149,840 Rx #436 Magnesium Sulfate 148,724 Rx #437 Cannabidiol 148,283 Rx

Utilization by Hyoscyamine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.125 mg sublingual tablet is the most-dispensed Hyoscyamine product — about 45% of these Medicaid prescriptions.

hyoscyamine sulfate 0.125 MG Sublingual Tablet Most dispensed

68,692 Medicaid prescriptions (Q1–Q4 2025) 45% of Hyoscyamine prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 6 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1046982

hyoscyamine sulfate 0.125 MG Oral Tablet

65,218 Medicaid prescriptions (Q1–Q4 2025) 43% of Hyoscyamine prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 5 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1047905

hyoscyamine sulfate 0.125 MG Disintegrating Oral Tablet

12,035 Medicaid prescriptions (Q1–Q4 2025) 8% of Hyoscyamine prescriptions shown $241,770 gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 4 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1046985

12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet

5,768 Medicaid prescriptions (Q1–Q4 2025) 4% of Hyoscyamine prescriptions shown $268,461 gross reimbursement (before rebates) ≈ $47 per prescription (gross)

Summed across the 3 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1046770

hyoscyamine sulfate 0.025 MG/ML Oral Solution

430 Medicaid prescriptions (Q1–Q4 2025) <1% of Hyoscyamine prescriptions shown $8,175 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1047881

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hyoscyamine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 20 of 140 listed Hyoscyamine NDCs with Medicaid activity.

Compare Hyoscyamine products

A representative set of FDA-listed product records for Hyoscyamine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 54 of 54 products — FDA National Drug Code Directory. See every product, package size and price: browse all 54 Hyoscyamine NDCs →

Hyoscyamine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Hyoscyamine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Hyoscyamine are nausea, diarrhoea, pain; about 62% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

10,205
Reports mentioning it
62%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
915
Diarrhoea
796
Pain
750
Fatigue
716
Headache
591
Dizziness
584
Vomiting
538
Abdominal Pain
535
Dyspnoea
494
Anxiety
453
Age groups
Adult · 819Elderly · 474Adolescent · 80Child · 54Infant · 10

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Hyoscyamine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Hyoscyamine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Hyoscyamine recalls since July 2021.

✅No Hyoscyamine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hyoscyamine RxCUI 153970 6 dose forms · 8 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 370665 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.125 MG RxCUI 1046985
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 378214 In current FDA listings
    Clinical drug / strength (SCD) Biphasic 12 HR hyoscyamine sulfate 0.375 MG RxCUI 1807886 12 HR hyoscyamine sulfate 0.375 MG RxCUI 1046770
  5. Dose form (SCDF) Oral Tablet RxCUI 370666 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.125 MG RxCUI 1047905
  6. Dose form (SCDF) Sublingual Tablet RxCUI 370667 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.125 MG RxCUI 1046982

Look up RxCUI 153970 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Hyoscyamine brand names

Hyoscyamine is sold under 16 brand names in the FDA directory — Cystospaz, ED-Spaz, Hyomax, Hyophen and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cystospaz ED-Spaz Hyomax Hyophen Hyosyne Levsin Oscimin Levbid Symax Anaspaz Ed Spaz NuLev Digenyx Hyoscyamine Sulfate TAB Hyoscyamine Sulfate SL Hyoscyamine sulfate Sublingual

Who makes Hyoscyamine: manufacturers and labelers

23 companies list Hyoscyamine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Chartwell RX, LLC, ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 6 Chartwell RX, LLC 6 ANI Pharmaceuticals, Inc. 4 Patrin Pharma, Inc. 4 Viatris Specialty LLC 4 Acella Pharmaceuticals, LLC 3 Granulation Technology, Inc. 3 Westminster Pharmaceuticals, LLC 3 Atlantic Biologicals Corp. 2 Lannett Company, Inc. 2 Larken Laboratories, Inc. 2 NCS HealthCare of KY, LLC dba Vangard Labs 2 Northwind Health Company, LLC 2 Remedyrepack Inc. 2 BPI Labs LLC 1 Direct_Rx 1 Laser Pharmaceuticals, LLC 1 Mylan Pharmaceuticals Inc. 1 PD-Rx Pharmaceuticals, Inc. 1 Proficient Rx LP 1 PureTek Corporation 1 QPharma, Inc. 1 Redpharm Drug 1

Hyoscyamine drug class (RxNorm)

Hyoscyamine belongs to the Belladonna alkaloids, tertiary amines class.

Drug family (ATC) Belladonna alkaloids, tertiary amines

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Hyoscyamine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 15, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hyoscyamine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hyoscyamine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
56
Finished products in the current FDA directory
54
Companies listing them (makers, repackagers, distributors)
23
FDA labeler codes behind them ⓘ
25
Linked representative label ⓘ
Wallace Pharmaceuticals Inc.
Linked label effective
Jul 15, 2023
Composite sections available
15
Linked SPL Set ID
5bbce8c0-a9c9-45b9-8457-1542bd3d9449
Linked SPL Document ID
0522d7a7-0349-48e2-85d9-827963cc4986
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Wallace Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →