Hyoscyamine sulfate Sublingual .125 mg Tablet, 120-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Belladonna alkaloids, tertiary amines class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.171 | $20.48 / 120 tablets |
| Medicaid paysCMS SDUD · 12 mo | $4.06 | $487.78 / 120 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hyoscyamine Sulfate SL .125 mg 42192-0339-01 | Acella | 100 tablets | $0.171 | — | Availability likely | — |
| Hyoscyamine sulfate Sublingual .125 mgthis 62135-0859-12 | Chartwell | 120 tablets | $0.171 | — | Availability likely | — |
| Hyoscyamine Sulfate .125 mg 62559-0424-01 | ANI | 100 tablets | $0.171 | — | Availability likely | — |
| Oscimin .125 mg 68047-0253-01 | Larken | 100 tablets | $0.171 | — | Availability likely | — |
| Levsin SL .125 mg 68220-0113-10 | Viatris | 100 tablets | $2.704 | — | Availability likely | +1485% |
| Hyoscyamine Sulfate .125 mg 00615-8554-39 | NCS | 30 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 39328-0051-10 | Patrin | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 63561-0202-01 | Granulation | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 63629-1031-01 | Bryant | 100 tablets | — | — | Discontinued | — |
| Hyoscyamine Sulfate SL .125 mg 69367-0678-01 | Westminster | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate SL .125 mg 71335-1159-01 | Bryant | 20 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 71335-1647-01 | Bryant | 20 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate .125 mg 72162-1940-01 | Bryant | 100 tablets | — | — | FDA listed | — |
| Hyoscyamine Sulfate Sublingual .125 mg 72189-0666-30 | Direct_Rx | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62135-0859-12 You're viewing this | 120 TABLET in 1 BOTTLE (62135-859-12) | 2024-09-20 | Active |
🧭 About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Is this NDC FDA-approved?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, 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). Also used in the treatment of infant colic (elixir and drops).
Hyoscyamine sulfate is 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 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. 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 ▾
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 ▾
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, 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported with 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; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; 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.
🆘 Overdosage ▾
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, 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 sulfate is dialyzable.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Hyoscyamine Sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia.
Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions. Hyoscyamine sulfate is absorbed totally and completely by sublingual administration as well as oral administration.
Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3 1/2 hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours.
Only traces of this drug are found in breast milk. Hyoscyamine sulfate passes the blood brain barrier and the placental barrier. The tablets can be taken orally with the same pharmacological effects occurring; however, the effects may not occur as rapidly as with sublingual administration.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hyoscyamine Sulfate Oral Drops (hyoscyamine sulfate oral solution, USP) (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, lemon flavored, and contains 5% ethyl alcohol. It is supplied in a 20 mL bottle (NDC 62135-513-52). Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, lemon flavored, and contains 20% ethyl alcohol.
It is supplied in a pint (473 mL) bottle (NDC 62135-511-47). Hyoscyamine Sulfate Tablets, USP , 0.125 mg are white to off -white, round tablets debossed with “ CE ” on one side and “ 116 ” on the other. Bottles of 120 (NDC 62135-512-12) Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg are white to off-white, round, flat-faced, beveled edge, strawberry flavored tablets, debossed with “ CE ” on one side and “ 222 ” on the other side Bottles of 120 (NDC 62135-859-12) Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white to off-white, round, flat-faced, beveled edge, strawberry flavored tablets, debossed with “ CE ” on one side and “ 221 ” on the other side.
Bottles of 120 (NDC 62135-858-12) Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in USP/NF. Rx only.
Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 09/2024 L70981
📋 Description ▾
DESCRIPTION Hyoscyamine Sulfate Oral Drops (Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration.
Hyoscyamine Sulfate Sublingual Tablets contain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration.
Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. 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: Hyoscyamine Sulfate Oral Drops also contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixir also contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose.
Hyoscyamine Sulfate Tablets also contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. "Structure"