HomeNDC LookupIngredientsHyoscyamine Sulfate › 68047-0252-01
OSCIMIN Hyoscyamine Sulfate .125 mg Tablet, 100-count — NDC 68047-0252-01 package photo

OSCIMIN Hyoscyamine Sulfate .125 mg Tablet, 100-count

by Larken Laboratories, Inc. · 100 TABLET in 1 BOTTLE (68047-252-01)
NDC 68047-0252-01
🏷️ FDA NDC (as labeled) 68047-252-01 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 68047-252-01
Product NDC 68047-252
11-digit billing NDC 68047025201
NCPDP billing unit EA — each (per item)
RxCUI 1047905, 1149355
UNII F2R8V82B84
UPC 0368047252012
SPL Set ID 8504adad-f6d0-4671-b655-4b62bf29a516
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-03
Route ORAL
Dosage form TABLET
Substance HYOSCYAMINE SULFATE
GPI-14 49101030100310
GPI class Oscimin
GCN Seq No 004865
GCN 18961
HICL code 002017
Ingredient (HICL) Hyoscyamine Sulfate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2A
Therapeutic class — specific (HIC3) Belladonna Alkaloids
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name OSCIMIN 0.125 MG TABLET
FDB brand name Oscimin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68047-252-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68047-0252-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Belladonna alkaloids, tertiary amines class.

Drug family (ATC) Belladonna alkaloids, tertiary amines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLarken Laboratories, Inc.
Labeler code68047
First marketedAug 2011
Product typeHuman Prescription Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OSCIMIN 0.125 MG TABLET Ingredient Hyoscyamine Sulfate
📖 What it is MedlinePlus · NLM

Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid. Hyoscyamine is also used in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, irritable bowel syndrome, cystitis, and pancreatitis. Hyoscyamine may also be used to treat certain heart conditions, to control the symptoms of Parkinson's disease and rhinitis (runny nose), and to reduce excess saliva production.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
📖 Read our full Hyoscyamine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color green
ShapeRound
ImprintLL;252
Size6 mm
ScoringNot scored
FlavorPeppermint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients include: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, lactose monohydrate, magnesium stearate (veg), mannitol, peppermint flavor, starch and stearic acid.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.152 $15.15 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3141 $31.41 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.195 $0.089
▲ Up 6% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hyoscyamine Sulfate TAB .125 mg 42192-0340-01 Acella 100 tablets $0.152 Availability likely
Hyoscyamine sulfate .125 mg 62135-0512-12 Chartwell 120 tablets $0.152 Availability likely
Hyoscyamine Sulfate .125 mg 62559-0421-01 ANI 100 tablets $0.152 Availability likely
Oscimin .125 mgthis 68047-0252-01 Larken 100 tablets $0.152 Availability likely
Levsin .125 mg 68220-0112-10 Viatris 100 tablets $2.657 Availability likely +1653%
Hyoscyamine Sulfate .125 mg 00615-8537-39 NCS 30 tablets FDA listed
Hyoscyamine Sulfate .125 mg 39328-0050-10 Patrin 100 tablets FDA listed
Hyoscyamine Sulfate TAB .125 mg 42708-0183-56 QPharma, 56 tablets FDA listed
Hyoscyamine Sulfate .125 mg 51655-0764-52 Northwind 30 tablets FDA listed
Hyoscyamine Sulfate TAB .125 mg 51655-0845-52 Northwind 30 tablets FDA listed
Digenyx .125 mg 59088-0150-54 PureTek 30 tablets FDA listed
Hyoscyamine Sulfate .125 mg 63629-1028-01 Bryant 100 tablets Discontinued
Hyoscyamine Sulfate TAB .125 mg 63629-5911-01 Bryant 20 tablets FDA listed
Hyoscyamine Sulfate .125 mg 69367-0677-01 Westminster 100 tablets FDA listed
Hyoscyamine Sulfate TAB .125 mg 70518-3847-00 REMEDYREPACK 90 tablets Discontinued
Hyoscyamine Sulfate .125 mg 70518-4436-00 REMEDYREPACK 180 tablets FDA listed
Hyoscyamine Sulfate .125 mg 72162-1939-01 Bryant 100 tablets FDA listed
Hyoscyamine Sulfate .125 mg 82804-0965-30 Proficient 30 tablets FDA listed
Hyoscyamine Sulfate .125 mg 63629-1030-01 Bryant 100 tablets Discontinued
Hyoscyamine Sulfate .125 mg 63629-1031-01 Bryant 100 tablets Discontinued
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 .125 mg 72162-1941-01 Bryant 100 tablets FDA listed
Hyoscyamine Sulfate SL .125 mg 69367-0678-01 Westminster 100 tablets FDA listed
Hyoscyamine Sulfate .125 mg 63561-0203-01 Granulation 100 tablets FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Aug 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68047-0252-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
378
Units reimbursed last 4 qtrs
16.7K
Gross reimbursed last 4 qtrs
$5.2K
Avg / prescription
$13.86
Avg / unit
$0.3141
Latest quarter Q4 2025
95Rx
Medicaid pays / ea
$0.3141
gross reimbursed
vs
NADAC / ea
$0.1515
acquisition cost
=
Spread
+$0.1626
+107% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% MCO
Fee-for-service · 0 Rx Managed care · 378 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 2,116 units · 30.8 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 9,353 units · 204 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 2,817 units · 25.5 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,396 units · 7.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.9204
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 204 /100k
2 Indiana 30.8 /100k
3 Georgia 25.5 /100k
4 Texas 7.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Oscimin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Oscimin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$991.92
Claims incl. refills
42
Beneficiaries
27
Spend / beneficiary
$36.74
Spend / claim
$23.62
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OSCIMIN (this brand).

Top reported reactions

Nausea167
Diarrhoea149
Fatigue143
Headache143
Pain136
Dizziness128
Dyspnoea93

Age at onset

Child9
Adolescent15
Adult193
Elderly141

Reporter sex

1,902 reports
Male · 23%
Female · 77%
Unknown · 0%

Serious outcomes

Hospitalization502
Death112
Disabling36
Life-threatening18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 187 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68047-0252-01 You're viewing this 100 TABLET in 1 BOTTLE (68047-252-01) 2011-08-03 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68047-252-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68047-0252-01, written without dashes as 68047025201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68047-0252-01, the first segment (68047) is the labeler code FDA assigned to Larken Laboratories, Inc.; the middle segment (0252) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Larken Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Larken Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 97 words

INDICATIONS AND USAGE 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.

⏱️ Dosage and Administration 70 words

DOSAGE AND ADMINISTRATION 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.

Contraindications 46 words

CONTRAINDICATIONS 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.

⚠️ Warnings 83 words

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.

🤒 Adverse Reactions 112 words

ADVERSE REACTIONS 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.

To report SUSPECTED ADVERSE REACTIONS, contact Larken Laborties, Inc. at 1-601-588-7678 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 52 words

Drug Interactions: 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.

🤰 Pregnancy 54 words

Pregnancy 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.

🧒 Pediatric Use 108 words

Pediatric Use: 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 Use 114 words

Geriatric Use: 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.

🆘 Overdosage 142 words

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 d 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.

🧬 Clinical Pharmacology 85 words

CLINICAL PHARMACOLOGY 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 disappears rapidly from 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.

📦 How Supplied / Storage and Handling 98 words

HOW SUPPLIED OSCIMIN Oral Tablets are supplied as round, green, peppermint flavored tablets with "LL" over “252” debossed on one side. Available in bottles of 100 tablets, NDC 68047-252-01. 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 .

Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 09/2025 201098-01

📦 Storage and Handling 69 words

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 . Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev.

09/2025 201098-01

🧪 Inactive Ingredients 27 words

INACTIVE INGREDIENTS Inactive ingredients include: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, lactose monohydrate, magnesium stearate (veg), mannitol, peppermint flavor, starch and stearic acid.

📋 Description 60 words

DESCRIPTION Each tablet for oral administration contains: Hyoscyamine Sulfate, USP …… 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. (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • 2H 2 O M.W. = 712.85 Hyoscyamine Sulfate

💬 Information for Patients 56 words

Information for Patients: 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.