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Dicyclomine Hydrochloride 10 mg Capsule, 60-count

by A-S Medication Solutions · 60 CAPSULE in 1 BOTTLE (50090-7340-2)

NDC 50090-7340-02

🏷️ FDA NDC (as labeled) 50090-7340-2 billing pads the package segment with a zero

This package

Contains60-count Pack sizes3 compare ↓

Also priced by: Part D plans $0.1589/unit — full pricing hub ↓

Also comes in: 30 capsules 50090-7340-00 90 capsules 50090-7340-08

Rx only Generic 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 →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Dicyclomine Hydrochloride (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Jul 23, 2026 — shortfill; reports of empty capsules. (Aurobindo Pharma USA Inc) · FDA recall D-0733-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 50090-7340-2

Product NDC 50090-7340

11-digit billing NDC 50090734002

NCPDP billing unit EA — each (per item)

RxCUI 991061

UNII CQ903KQA31

Application # ANDA217054

SPL Set ID 59422db6-b22d-447a-9393-46347406b338

Established class (EPC) Anticholinergic

Mechanism of action Cholinergic Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-02-01

Route ORAL

Dosage form CAPSULE

Substance DICYCLOMINE HYDROCHLORIDE

GCN Seq No 004918

GCN 19261

HICL code 002045

Ingredient (HICL) Dicyclomine Hcl

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J2

Therapeutic class — intermediate (HIC2) Anticholinergics

HIC3 code J2D

Therapeutic class — specific (HIC3) Anticholinergics/Antispasmodics

AHFS code 12:08.08.00

AHFS class Antimuscarinics/Antispasmodics

FDB label name DICYCLOMINE 10 MG CAPSULE

FDB brand name Dicyclomine Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 50090-7340-2 — a 5-4-1 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 package segment → 50090-7340-02. 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 Anticholinergic class.

Pharmacologic class Anticholinergic

Drug family (ATC) Synthetic anticholinergics, esters with tertiary amino group

How it works Cholinergic Antagonists

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

LabelerA-S Medication Solutions

Application holderTWI PHARMACEUTICALS INC

FDA applicationANDA217054 (ANDA)

Labeler code50090

First marketedFeb 2023

Product typeHuman Prescription Drug

Portfolio2,774 products on file

🔎 All NDCs from A-S Medication Solutions

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 DICYCLOMINE 10 MG CAPSULE Ingredient Dicyclomine Hcl

📖 What it is MedlinePlus · NLM

Dicyclomine is used to treat the symptoms of irritable bowel syndrome. Dicyclomine is in a class of medications called anticholinergics. It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Dicyclomine relaxes the overactive muscles in your intestines that cause IBS cramping and pain — it works both by blocking certain nerve signals and by directly calming the gut mus...
What exactly does dicyclomine do, and how quickly will I notice it working?
The most common ones are dizziness, dry mouth, and blurred vision — these showed up in a significant number of patients in clinical trials. You might also notice some nausea, drows...
What are the most common side effects I should expect?

📖 Read our full Dicyclomine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 white

ShapeCapsule

ImprintTWiT201;10mg

Size14 mm

ScoringNot scored

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 WAT0DDB505
Calcium sulfate is a mineral compound used as a filler and binder in tablets and capsules. It helps give the medicine its solid structure and ensures consistent dosing.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1589	$9.53 / 60 capsules

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dicyclomine hydrochloride 10 mg 00054-0748-25	Hikma	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 00527-0586-01	Lannett	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 00591-0794-01	Actavis	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine hydrochloride 10 mg 00832-6053-10	Upsher-Smith	1000 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 00904-6987-61	Major	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 16571-0260-01	Rising	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 24979-0201-01	Upsher-Smith	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine hydrochloride 10 mg 31722-0052-01	Camber	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine hydrochloride 10 mg 43547-0634-10	Solco	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 50268-0199-15	AvPAK	50 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 59651-0719-01	Aurobindo	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 60687-0369-01	American	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 62135-0718-90	Chartwell	90 capsules	$0.076	AB	Availability likely	—
Dicyclomine Hydrochloride 10 mg 73473-0800-01	Solaris	100 capsules	$0.076	AB	Availability likely	—
Dicyclomine hydrochloride 10 mg 00615-8483-39	NCS	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 42708-0160-56	QPharma,	56 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 43063-0112-04	PD-Rx	4 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 43063-0629-28	PD-Rx	28 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 50090-0126-00	A-S	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 50090-0127-00	A-S	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mgthis 50090-7340-02	A-S	60 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 50090-7341-01	A-S	28 capsules	—	AB	FDA listed	—
Dicyclomine hydrochloride 10 mg 50090-7729-00	A-S	30 capsules	—	AB	FDA listed	—
Dicyclomine hydrochloride 10 mg 51407-0783-01	Golden	100 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 51655-0219-27	Northwind	12 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 55154-3565-00	Cardinal	10 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 55154-8183-00	Cardinal	10 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 55289-0923-20	PD-Rx	20 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 55700-0766-30	Quality	30 capsules	—	AB	Discontinued	—
Dicyclomine Hydrochloride 10 mg 63187-0196-30	Proficient	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 66267-0291-30	NuCare	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 67046-1258-03	Coupler	30 capsules	—	AB	FDA listed	—
Dicyclomine hydrochloride 10 mg 67046-1513-03	Coupler	30 capsules	—	AB	FDA listed	—
Dicyclomine hydrochloride 10 mg 67296-2158-03	Redpharm	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 68071-3035-03	NuCare	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 68071-3310-01	NuCare	16 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 68071-3674-03	NuCare	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 68788-8578-01	Preferred	100 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 70518-4331-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 70518-4432-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 71205-0428-15	Proficient	15 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 71335-0471-01	Bryant	30 capsules	—	AB	Discontinued	—
Dicyclomine Hydrochloride 10 mg 71335-0938-01	Bryant	30 capsules	—	AB	Discontinued	—
Dicyclomine Hydrochloride 10 mg 71335-2316-01	Bryant	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 71335-9709-01	Bryant	30 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 71610-0265-09	Aphena	9000 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 72162-2613-00	Bryant	1000 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 72789-0522-01	PD-Rx	100 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 72789-0546-28	PD-Rx	28 capsules	—	AB	FDA listed	—
Dicyclomine hydrochloride 10 mg 72888-0105-00	Advagen	1000 capsules	—	AB	FDA listed	—
Dicyclomine Hydrochloride 10 mg 67296-2310-03	Redpharm	30 capsules	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2023

On the market since

Feb 2023

📍

2026

Currently FDA-listed

3 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 Dicyclomine hydrochloride — the ingredient across all brands.

Top reported reactions

Nausea1,333

Diarrhoea1,305

Fatigue1,172

Pain1,038

Headache909

Abdominal Pain744

Vomiting741

Age at onset

Child11

Adolescent84

Adult1,585

Elderly935

Reporter sex

Serious outcomes

Hospitalization4,287

Death848

Disabling357

Life-threatening267

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
50090-7340-00	30 CAPSULE in 1 BOTTLE (50090-7340-0)	2024-10-16	Active
50090-7340-02 You're viewing this	60 CAPSULE in 1 BOTTLE (50090-7340-2)	2024-10-16	Active
50090-7340-08	90 CAPSULE in 1 BOTTLE (50090-7340-8)	2024-10-16	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 50090-7340-02?

NDC 50090-7340-02 is a 60-count package — 60 capsule in 1 bottle.

What is the difference between NDC 50090-7340-02 and NDC 50090-7340-00?

Both are Dicyclomine Hydrochloride 10 mg Capsule — the drug itself is identical. NDC 50090-7340-02 is the 60-count package, while NDC 50090-7340-00 is the 30 capsules package.

What NDC number is used to bill for this package of Dicyclomine Hydrochloride 10 mg Capsule?

Bill NDC 50090-7340-02 — the 11-digit billing format is 50090734002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

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)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
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)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

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 50090-7340-2, 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: 50090-7340-02, written without dashes as 50090734002. 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 50090-7340-02, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (7340) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 30 capsules (50090-7340-00), 90 capsules (50090-7340-08). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

A-S Medication Solutions 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 40 words ▾

1 INDICATIONS AND USAGE Dicyclomine hydrochloride capsules are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )

⏱️ Dosage and Administration 191 words ▾

2 DOSAGE AND ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine hydrochloride capsules must be adjusted to individual patient needs ( 2 ). If a dose is missed, patients should continue the normal dosing schedule ( 2 ).

Oral in adults ( 2.1 ): Starting dose: 20 mg four times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation Discontinue dicyclomine hydrochloride capsules if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment

2.1Oral Dosage and Administration in Adults The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued.

Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS Dicyclomine Hydrochloride Capsules USP, 10 mg: white capsules with "TWi T201" ink and white body with"10 mg" ink, and the capsule contains white to off white powder blend. Dicyclomine Hydrochloride Capsules USP, 10 mg ( 3 )

⛔ Contraindications 158 words ▾

4 CONTRAINDICATIONS Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations ( 8.4 )] , nursing mothers [see Use in Specific Populations ( 8.3 )] , and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis [see Warnings and Precautions ( 5.4 )] glaucoma [see Adverse Reactions ( 6.3 ) and Drug Interactions ( 7.1 )] obstructive uropathy [see Warnings and Precautions ( 5.8 )] obstructive disease of the gastrointestinal tract [see Warnings and Precautions ( 5.5 )] severe ulcerative colitis [see Warnings and Precautions ( 5.7 )] reflux esophagitis Infants less than 6 months of age ( 4 ) Nursing mothers ( 4 ) Unstable cardiovascular status in acute hemorrhage ( 4 ) Myasthenia gravis ( 4 ) Glaucoma ( 4 ) Obstructive uropathy ( 4 ) Obstructive disease of the gastrointestinal tract ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular conditions: worsening of conditions ( 5.2 ) Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted ( 5.3 ) Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride capsules ( 5.3 ) Myasthenia Gravis: overdose may lead to muscular weakness and paralysis.

Dicyclomine hydrochloride capsules should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4 ) Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride capsules would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients: due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis: Dicyclomine hydrochloride capsules should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon ( 5.7 ) Prostatic hypertrophy: Dicyclomine hydrochloride capsules should be used with caution in these patients; may lead to urinary retention ( 5.8 ) Hepatic and renal disease: should be used with caution ( 5.9 ) Geriatric: use with caution in elderly who may be more susceptible to dicyclomine hydrochloride capsules’s adverse events ( 5.10 )

5.2Cardiovascular Conditions Dicyclomine hydrochloride capsules need to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride capsules. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions ( 6.3 )] .

5.3Peripheral and Central Nervous System The peripheral effects of dicyclomine hydrochloride capsules are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions ( 6 )] .

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted.

Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/or in patients with mental illness) given anticholinergic drugs.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug. Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology ( 12 )] . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

The most serious adverse reactions reported with dicyclomine hydrochloride capsules include cardiovascular and central nervous system symptoms [see Warnings and Precautions ( 5.2 , 5.3 )] . The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TWi Pharmaceuticals, Inc. at 1-844-518-2989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) Placebo % % Dry Mouth 33 5 Dizziness 40 5 Vision blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group).

In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

6.2Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac disorders: palpitations, tachyarrhythmias Eye disorders: cycloplegia, mydriasis, vision blurred Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting General disorders and administration site conditions: fatigue, malaise Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock Nervous system disorders: dizziness, headache, somnolence, syncope Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Dicyclomine.

Nervousness and insomnia have also been reported. Reproductive system and breast disorders: suppressed lactation Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion Skin a…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antiglaucoma agents: anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure ( 7 ) Anticholinergic agents: may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs ( 7 ) Antacids: interfere with the absorption of anticholinergic agents ( 7 )

7.1Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Contraindications ( 4 )] .

7.2Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

7.3Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

7.4Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.

7.5Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

7.6Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: use only if clearly needed ( 8.1 ) Pediatric Use: Safety and effectiveness not established ( 8.4 ) Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function ( 8.6 )

8.1Pregnancy Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3Nursing Mothers Dicyclomine hydrochloride is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in breastmilk. Because of the potential for serious adverse reactions in breastfed infants from dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations ( 8.4 )] .

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Contraindications ( 4 )] . There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

8.5Geriatric Use Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Renal Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride has not been studied. Dicyclomine hydrochloride drug are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.

8.7Hepatic Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

🤰 Pregnancy 124 words ▾

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 79 words ▾

🧓 Geriatric Use 113 words ▾

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the dicyclomine. The acute oral LD 50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [see Warnings and Precautions ( 5 )] , the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not known if dicyclomine hydrochloride is dialyzable. Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement.

If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

12.2Pharmacodynamics Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function

12.3Pharmacokinetics Absorption and Distribution In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately

3.65L/kg suggesting extensive distribution in tissues. Elimination The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).

Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

🧬 Mechanism of Action 152 words ▾

📦 How Supplied / Storage and Handling 28 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-7340 NDC: 50090-7340-0 30 CAPSULE in a BOTTLE NDC: 50090-7340-2 60 CAPSULE in a BOTTLE NDC: 50090-7340-8 90 CAPSULE in a BOTTLE

📋 Description 128 words ▾

11 DESCRIPTION Dicyclomine hydrochloride capsules, USP, are antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage forms: Dicyclomine Hydrochloride Capsules, USP, 10 mg for oral use contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide black. Dicyclomine hydrochloride, USP is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste.

It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. FDA approved dissolution test specifications differ from USP. image description

💬 Information for Patients 194 words ▾

17 PATIENT COUNSELING INFORMATION

17.2Use in Infants Inform parents and caregivers not to administer dicyclomine hydrochloride in infants less than 6 months of age [see Use in Specific Populations ( 8.4 )].

17.3Use in Nursing Mothers Advise lactating women that dicyclomine hydrochloride should not be used while breastfeeding their infants [see Use in Specific Populations ( 8.3 , 8.4 )] .

17.4Peripheral and Central Nervous System In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision.

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 dicyclomine hydrochloride [see Warnings and Precautions ( 5.3 )] . Manufactured for: TWi Pharmaceuticals USA, Inc. Paramus, NJ 07652 Manufactured by: TWi Pharmaceuticals, Inc.

Taoyuan City, 320023, Taiwan BENTYL ® is a registered trademark owned by Aptalis Pharma Canada Inc., an affiliated company of Aptalis Pharma US, Inc. Rev. 06/2022 image description

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

apnea: A pause or temporary stop in breathing.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

delusion: A false belief that a person holds strongly even when there is clear evidence that it is not true.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysarthria: Slurred or slow speech caused by weakness or poor control of the muscles used for speaking.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

euphoria: An intense feeling of happiness or well-being that is stronger than a normal good mood.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intraocular pressure: The fluid pressure inside the eye.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urinary retention: Being unable to empty the bladder fully or at all.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 50090-7339-00 · A-S 50090-7341-01 · A-S →

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.

Dicyclomine Hydrochloride 10 mg Capsule, 60-count

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