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Dicyclomine Hydrochloride 20 mg Tablet, 60-count — NDC 71335-2341-03 package photo

Dicyclomine Hydrochloride 20 mg Tablet, 60-count

by Bryant Ranch Prepack · 60 TABLET in 1 BOTTLE (71335-2341-3)
NDC 71335-2341-03
🏷️ FDA NDC (as labeled) 71335-2341-3 billing pads the package segment with a zero
This package
Contains60-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1535/unit — full pricing hub ↓
Also comes in: 20 tablets 71335-2341-05 21 tablets 71335-2341-06 28 tablets 71335-2341-09 30 tablets 71335-2341-01 40 tablets 71335-2341-02 90 tablets 71335-2341-04 100 tablets 71335-2341-08 120 tablets 71335-2341-07
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

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) 71335-2341-3
Product NDC 71335-2341
11-digit billing NDC 71335234103
RxCUI 991086
UNII CQ903KQA31
Application # ANDA040317
SPL Set ID 226a3a6e-9419-448a-827f-01199b792762
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 2023-04-25
Route ORAL
Dosage form TABLET
Substance DICYCLOMINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-2341-3 — 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 → 71335-2341-03. 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

LabelerBryant Ranch Prepack
Application holderAUROBINDO PHARMA USA INC
FDA applicationANDA040317 (ANDA)
Labeler code71335
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio4,433 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

📖 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 →

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 Blue
ShapeRound
ImprintD20
Size7 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 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 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.

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 systemPer eachPer 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 $0.1535 $9.21 / 60 tablets
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
Dicyclomine hydrochloride 20 mg 00832-6052-10 Upsher-Smith 1000 tablets $0.056 AB Discontinued —
Dicyclomine 20 mg 00143-1227-01 Hikma 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 00527-1282-01 Lannett 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 00591-0795-01 Actavis 100 tablets $0.059 — Availability likely —
Dicyclomine Hydrochloride 20 mg 00904-6988-61 Major 100 tablets $0.059 AB Availability likely —
Dicyclomine hydrochloride 20 mg 16571-0259-01 Rising 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 24979-0200-01 Upsher-Smith 100 tablets $0.059 AB Availability likely —
Dicyclomine hydrochloride 20 mg 31722-0079-01 Camber 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 59651-0720-01 Aurobindo 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 60687-0380-01 American 100 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 62135-0428-12 Chartwell 120 tablets $0.059 AB Availability likely —
Dicyclomine Hydrochloride 20 mg 69452-0311-20 Bionpharma 100 tablets $0.059 AB Availability likely —
Dicyclomine hydrochloride 20 mg 72888-0119-00 Advagen 1000 tablets $0.059 — Availability likely —
Dicyclomine Hydrochloride 20 mg 73473-0902-01 Solaris 100 tablets $0.059 AB Availability likely —
Dicyclomine hydrochloride 20 mg 00615-8622-39 NCS 30 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 43063-0045-04 PD-Rx 4 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 50090-1577-00 A-S 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 50090-7309-00 A-S 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 50090-7732-00 A-S 30 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 50090-7882-00 A-S 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 51407-0821-12 Golden 120 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 51655-0257-26 Northwind 90 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 51655-0548-26 Northwind 90 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 51655-0940-26 Northwind 90 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 60760-0665-30 St. 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 60760-0802-30 St. 30 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 60760-0931-30 St. 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 63187-0410-15 Proficient 15 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 63187-0784-15 Proficient 15 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 67046-1164-03 Coupler 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 67296-2142-01 Redpharm 10 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 67296-2154-01 Redpharm 15 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 67296-2175-01 Redpharm 10 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 67296-2226-05 Bionpharma 56 tablets — AB Discontinued —
Dicyclomine Hydrochloride 20 mg 68071-3255-01 NuCare 10 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68071-3555-03 NuCare 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68071-3606-06 NuCare 6 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68071-3645-03 NuCare 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68071-3648-06 NuCare 100 tablets — AB FDA listed —
Dicyclomine 20 mg 68071-3782-03 NuCare 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 68071-3885-02 NuCare 20 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 68071-3916-06 NuCare 6 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68071-4782-01 NuCare 10 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 68071-5298-03 NuCare 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68788-7811-02 Preferred 20 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 68788-8751-02 Preferred 20 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 70518-1767-00 REMEDYREPACK 30 tablets — AB Discontinued —
Dicyclomine Hydrochloride 20 mg 70518-3917-00 REMEDYREPACK 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 70518-4393-00 REMEDYREPACK 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 70518-4555-00 REMEDYREPACK 180 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 71335-0425-01 Bryant 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 71335-2226-01 Bryant 30 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mgthis 71335-2341-03 Bryant 60 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 71335-2506-00 Bryant 10 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 71610-0209-09 Aphena 9000 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 72162-1077-03 Bryant 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 72162-2612-00 Bryant 1000 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 72789-0466-01 PD-Rx 100 tablets — — FDA listed —
Dicyclomine Hydrochloride 20 mg 72789-0539-01 PD-Rx 100 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 82868-0103-30 Northwind 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 87441-0007-01 Unit 30 tablets — AB FDA listed —
Dicyclomine Hydrochloride 20 mg 67296-2294-04 Redpharm 15 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 68788-4146-03 Preferred 30 tablets — AB FDA listed —
Dicyclomine hydrochloride 20 mg 67296-2311-02 Redpharm 15 tablets — 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
Apr 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

0 reports

Serious outcomes

Hospitalization4,287
Death848
Disabling357
Life-threatening267
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1,343 691
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
71335-2341-01 30 TABLET in 1 BOTTLE (71335-2341-1) 2024-02-06 Active
71335-2341-02 40 TABLET in 1 BOTTLE (71335-2341-2) 2024-02-06 Active
71335-2341-03 You're viewing this 60 TABLET in 1 BOTTLE (71335-2341-3) 2024-02-06 Active
71335-2341-04 90 TABLET in 1 BOTTLE (71335-2341-4) 2024-02-06 Active
71335-2341-05 20 TABLET in 1 BOTTLE (71335-2341-5) 2024-02-06 Active
71335-2341-06 21 TABLET in 1 BOTTLE (71335-2341-6) 2024-02-06 Active
71335-2341-07 120 TABLET in 1 BOTTLE (71335-2341-7) 2024-02-06 Active
71335-2341-08 100 TABLET in 1 BOTTLE (71335-2341-8) 2024-02-06 Active
71335-2341-09 28 TABLET in 1 BOTTLE (71335-2341-9) 2024-02-06 Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2341-03?
NDC 71335-2341-03 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 71335-2341-03 and NDC 71335-2341-05?
Both are Dicyclomine Hydrochloride 20 mg Tablet — the drug itself is identical. NDC 71335-2341-03 is the 60-count package, while NDC 71335-2341-05 is the 20 tablets package.
What NDC number is used to bill for this package of Dicyclomine Hydrochloride 20 mg Tablet?
Bill NDC 71335-2341-03 — the 11-digit billing format is 71335234103. 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 71335-2341-3, 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: 71335-2341-03, written without dashes as 71335234103. 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 71335-2341-03, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2341) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Bryant Ranch Prepack. 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 8 other package presentations of this same product, including 20 tablets (71335-2341-05), 21 tablets (71335-2341-06), 28 tablets (71335-2341-09). 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?
Bryant Ranch Prepack 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 39 words ▾

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

⏱️ Dosage and Administration 187 words ▾

2 DOSAGE AND ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine 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 4 times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg 4 times a day, unless side effects limit dosage escalation Discontinue dicyclomine if efficacy not achieved or side effects require doses less than 80 mg per day after 2 weeks of treatment

2.1Oral Dosage and Administration in Adults The recommended initial dose is 20 mg 4 times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg 4 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 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Dicyclomine hydrochloride tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP. The 20 mg tablets are a blue, round, flat-faced, beveled edge tablet debossed with D 20 on one side of the tablet and blank on the other side. Dicyclomine hydrochloride tablets 20 mg ( 3 )

⛔ Contraindications 147 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 ( 5.3 ) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis.

Dicyclomine 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 would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients : due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis : Dicyclomine 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 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’s adverse events ( 5.10 )

5.2Cardiovascular Conditions Dicyclomine hydrochloride needs 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. 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 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 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 or performing hazardous work while taking dicyclomine.

5.4Myasthenia Gravis With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscul…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The pattern of adverse effects seen with dicylomine 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 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 4 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 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. 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 anticholinergic 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 and Subcutaneous Tissue Disorder: dermatitis al…

🔄 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 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: 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, 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 in pregnant women at the recommended doses of 80 mg/day 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 is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine, 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 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 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 have not been studied. Dicyclomine drug is 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 should be administered with caution in patients with renal impairment.

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

🤰 Pregnancy 124 words ▾

8.1Pregnancy Pregnancy Category B: Adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day 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.

🧒 Pediatric Use 76 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine 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.

🧓 Geriatric Use 112 words ▾

8.5Geriatric Use Clinical studies of dicyclomine 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.

🆘 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 4 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 (5.1) ], the blood concentrations of drug were 200 ng/mL, 220 ng/mL, and 505 ng/mL.

It is not known if dicyclomine 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 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 to 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 ▾

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.

📦 How Supplied / Storage and Handling 154 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine hydrochloride tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP. The 20 mg tablets are a blue, round, flat-faced, beveled edge tablet debossed with D 20 on one side of the tablet and blank on the other side. NDC: 71335-2341-1: 30 Tablets in a BOTTLE NDC: 71335-2341-2: 40 Tablets in a BOTTLE NDC: 71335-2341-3: 60 Tablets in a BOTTLE NDC: 71335-2341-4: 90 Tablets in a BOTTLE NDC: 71335-2341-5: 20 Tablets in a BOTTLE NDC: 71335-2341-6: 21 Tablets in a BOTTLE NDC: 71335-2341-7: 120 Tablets in a BOTTLE NDC: 71335-2341-8: 100 Tablets in a BOTTLE NDC: 71335-2341-9: 28 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] To prevent fading, avoid exposure to direct sunlight.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 102 words ▾

11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula: Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.

Dicyclomine hydrochloride tablets, USP for oral administration contain 20 mg of dicyclomine hydrochloride, USP. In addition each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate.

💬 Information for Patients 165 words ▾

17 PATIENT COUNSELING INFORMATION

17.2Use in Infants Inform parents and caregivers not to administer dicyclomine 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 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 use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine 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 [see Warnings and Precautions (5.3) ]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2023

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-2340-01 · Bryant 71335-2342-01 · Bryant →
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.