Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule, 120-count — NDC 62135-0696-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule, 120-count — NDC 62135-696-12 (Billing 62135-0696-12)

by Chartwell RX, LLC · 120 CAPSULE in 1 BOTTLE

This is a package of 120 capsules of Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule from Chartwell RX, LLC, marketed since Oct 2020 and currently FDA-listed; retail pharmacies pay about $0.2561 per capsule (NADAC). It is this product's only package size.

NDC 62135-0696-12
🏷️ FDA NDC (as labeled) 62135-696-12 billing pads the product segment with a zero
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 62135-696-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
62135 labeler · 696 product · 12 package
Package marketed since
Jun 8, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
120 EA per package
Barcode (UPC)
0362135696122
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-696-12
Product NDC 62135-696
11-digit billing NDC 62135069612
NCPDP billing unit EA — each (per item)
RxCUI 889614
UNII MFM6K1XWDK, 91ZQW5JF1Z
UPC 0362135696122
Application # ANDA213530
SPL Set ID a0d735c2-e7a9-4843-a78d-203c9598682d
Established class (EPC) Anticholinergic; Benzodiazepine
Mechanism of action Cholinergic Antagonists
Physiologic effect Decreased Parasympathetic Acetylcholine Activity; Digestive/GI System Activity Alteration; GI Motility Alteration
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-20
Route ORAL
Dosage form CAPSULE
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 49109902450110
GPI class chlordiazePOXIDE-Clidinium
GCN Seq No 004902
GCN 74801
HICL code 002037
Ingredient (HICL) Chlordiazepoxide/Clidinium Br
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2B
Therapeutic class — specific (HIC3) Anticholinergics,Quaternary Ammonium
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name CHLORDIAZEPOXIDE-CLIDINIUM CAP
FDB brand name Chlordiazepoxide-Clidinium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004902
  • GCN: 74801
  • GPI-14 (Medi-Span): 49109902450110
  • HICL (First Databank): 002037
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 889614
Why two NDCs? The FDA registers this code as 62135-696-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0696-12. 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
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.

Clinical

Label name CHLORDIAZEPOXIDE-CLIDINIUM CAP Ingredient Chlordiazepoxide/Clidinium Br
📖 What it is MedlinePlus · NLM

The combination of chlordiazepoxide and clidinium is used along with other medications to treat peptic ulcers, irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea), and enterocolitis (swelling in the intestines). Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain. Clidinium is in a class of medications called anticholinergics. It helps to decrease stomach spasms and cramps.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used for stomach and bowel problems that have a stress or emotional component. It can also be added to other treatment for peptic ulcer, irritable bowel syndrome and acute ent...
  • Take it by mouth, usually before meals and at bedtime, exactly as your prescriber directs. Your dose is individualized, so follow your label. Don't stop suddenly if you've been on...
  • Dry mouth, blurry vision, trouble starting urination and constipation are the most typical. Drowsiness, unsteadiness and confusion can also happen, especially in older adults. Call...
  • Avoid alcohol. Opioid pain medicines are a serious concern, since the combination can cause dangerous sleepiness, slowed breathing, coma and death. Tell me or your doctor about eve...
📖 Read our full Chlordiazepoxide and Clidinium guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.256 $30.73 / 120 capsules
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 · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2022 Feb 2024 Apr 2026 Sep 2026 $0.474 $0.241
▼ Down 46% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0696-12 You're viewing this Main listing 120 CAPSULE in 1 BOTTLE 2022-06-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 11534-0197-01 Sunrise 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hcl And Clidinium Bromide 5 mg/1; 2.5 mg 42571-0381-01 Micro 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 59651-0524-01 Aurobindo 100 capsules $0.256 AB Availability likely —
chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 60219-1677-01 Amneal 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 60687-0639-94 American 20 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride And Clidinium Bromide 5 mg/1; 2.5 mgthis 62135-0696-12 Chartwell 120 capsules $0.256 AB Availability likely —
Chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 62332-0744-31 Alembic 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 67877-0731-01 Ascend 100 capsules $0.256 AB Availability likely —
Librax 5 mg/1; 2.5 mg 00187-4100-10 Bausch 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 00276-0500-10 Misemer 100 capsules — AB FDA listed —
Chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 46708-0744-31 Alembic 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 63629-2373-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 63629-8859-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 71335-2966-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 71335-9764-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 72162-1237-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hcl And Clidinium Bromide 5 mg/1; 2.5 mg 72162-2436-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 75826-0134-10 Winder 100 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

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color green
ShapeCapsule
Imprint696;696
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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

12 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.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA213530 (ANDA)
Labeler code62135
First marketedOct 2020
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio521 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 64 words ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS ). Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

🎯 Indications and Usage 57 words ▾

INDICATIONS AND USAGE Chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

⏱️ Dosage and Administration 107 words ▾

DOSAGE AND ADMINISTRATION Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Geriatric Dosing Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 chlordiazepoxide hydrochloride and clidinium bromide capsules per day, to be increased gradually as needed and tolerated.

⛔ Contraindications 49 words ▾

CONTRAINDICATIONS Chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.

⚠️ Warnings ~1 min read ▾

WARNINGS Concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe chlordiazepoxide hydrochloride and clidinium bromide capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide hydrochloride and clidinium bromide capsules is used with opioids (see PRECAUTIONS ) . As in the case of other preparations containing CNS-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide capsules should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants.

For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle. Usage In Pregnancy An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided.

The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see ANIMAL PHARMACOLOGY ) .

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS No side effects or manifestation not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. However, since the chlordiazepoxide hydrochloride and clidinium bromide capsules contain chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When chlordiazepoxide hydrochloride has been used alone the necessity of discontinuing therapy because of undesirable effects has been rare.

Drowsiness, ataxia and confusion have been reported in some patients – particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.

Other adverse reactions reported during therapy with chlordiazepoxide hydrochloride include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable. Adverse effects reported with use of chlordiazepoxide hydrochloride and clidinium bromide capsules are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation.

Constipation has occurred most often when Chlordiazepoxide Hydrochloride/Clidinium Bromide therapy has been combined with other spasmolytic agents and/or low residue diet. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Manifestations of chlordiazepoxide hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide hydrochloride overdosage. While the signs and symptoms of chlordiazepoxide hydrochloride and clidinium bromide capsules overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide.

The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute.

This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol.

Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used.

As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested. Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE ).

📦 How Supplied / Storage and Handling 99 words ▾

HOW SUPPLIED Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg are available in green opaque hard gelatin capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 120 (NDC 62135-696-12) with imprinted "696" on the cap and body of the capsule in black ink. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Dispense in tight, light-resistant container as defined in USP/NF. Manufactured for: Chartwell RX, LLC Congers, NY 10920 Revised: 04/2022 L70906

📋 Description 219 words ▾

DESCRIPTION Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, sodium lauryl sulfate, D&C Yellow No.

10, FD&C Green No. 3, titanium dioxide, and gelatin. The imprinting ink contains ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac.

Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds.

Chlordiazepoxide hydrochloride is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 2-oxide monohydrochloride. A white to slightly yellow, crystalline powder, it is soluble in water. It is unstable in solution and the powder must be protected from light.

The molecular weight is 336.2. The structural formula of chlordiazepoxide hydrochloride is as follows: Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. Structurally clidinium bromide is: "Image Description" "Image Description"

💬 Medication Guide ~2 min read ▾

MEDICATION GUIDE Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules (klor dye az e pox' ide) (kli di' nee um) What is the most important information I should know about chlordiazepoxide hydrochloride and clidinium bromide capsules?Do not stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. Stopping chlordiazepoxide hydrochloride and clidinium bromide capsules suddenly can cause serious side effects. Taking chlordiazepoxide hydrochloride and clidinium bromide capsules with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide hydrochloride and clidinium bromide capsules affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide hydrochloride and clidinium bromide capsules without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide hydrochloride and clidinium bromide capsules may make your sleepiness or dizziness much worse. chlordiazepoxide hydrochloride and clidinium bromide capsules can cause abuse and dependence.

Do not stop taking chlordiazepoxide hydrochloride and clidinium bromide capsules all of a sudden. Stopping chlordiazepoxide hydrochloride and clidinium bromide capsules suddenly can cause seizures, shaking, stomach and muscle cramps, vomiting and sweating. Physical dependence is not the same as drug addiction.

Your healthcare provider can tell you more about What are chlordiazepoxide hydrochloride and clidinium bromide capsules? Chlordiazepoxide hydrochloride and clidinium bromide capsules are a prescription medicine that are used with other therapies for the treatment of: stomach (peptic) ulcers irritable bowel syndrome (IBS) inflammation of the colon called acute enterocolitis chlordiazepoxide hydrochloride and clidinium bromide capsules contains the medicines chlordiazepoxide HCl and clidinium bromide. chlordiazepoxide hydrochloride and clidinium bromide capsules can be abused or lead to dependence.

Keep chlordiazepoxide hydrochloride and clidinium bromide capsules in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide hydrochloride and clidinium bromide capsules may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

It is not known if chlordiazepoxide hydrochloride and clidinium bromide capsules are safe and effective in children. Do not take chlordiazepoxide hydrochloride and clidinium bromide capsules if you: have glaucoma have an enlarged prostate have a blockage of your bladder that causes problems with urination are allergic to chlordiazepoxide hydrochloride or clidinium bromide Before you take chlordiazepoxide hydrochloride and clidinium bromide capsules, tell your healthcare provider about all of your medical conditions, including if you: have eye problems have problems urinating or emptying your bladder have coordination problems have kidney or liver problems have a history of depression, mental illness, or suicidal thoughts have a history of drug or alcohol abuse or addiction have bleeding problems are pregnant or plan to become pregnant.

Chlordiazepoxide hydrochloride and clidinium bromide capsules may harm your unborn baby. Avoid taking chlordiazepoxide hydrochloride and clidinium bromide capsules during the first trimester of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment with chlordiazepoxide hydrochloride and clidinium bromide capsules are breastfeeding or plan to breastfeed.

Chlordiazepoxide hydrochloride and clidinium bromide capsules may pass through your breast milk and may harm your baby. T… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS In debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide Hydrochloride/Clidinium Bromide capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of chlordiazepoxide hydrochloride and clidinium bromide capsules and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed - particularly when the known potentiating compounds such as the MAO inhibitors and phenothiazines are to be used.

The usual precautions in treating patients with impaired renal or hepatic function should be observed. Paradoxical reactions to chlordiazepoxide hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during chlordiazepoxide hydrochloride and clidinium bromide capsules therapy. The usual precautions are indicated when chlordiazepoxide hydrochloride is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary.

Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide hydrochloride. Information for Patients Inform patients and caregivers that potentially fatal additive effects may occur if chlordiazepoxide hydrochloride and clidinium bromide capsules is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS ).

To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.

When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving chlordiazepoxide hydrochloride and clidinium bromide capsules. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see DOSAGE AND ADMINISTRATION ).Chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS ).

🔒 Drug Abuse and Dependence 127 words ▾

DRUG ABUSE AND DEPENDENCE Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months.

Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

📄 Package Label / Principal Display Panel 19 words ▾

PACKAGE LABEL,PRINICIPAL DISPLAY PANEL Chlordiazepoxide HCL and Clidinium Bromide Capsules,USP- NDC-62135-696 - 12 - 120's Bottle Label "Image Description"

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

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 Chlordiazepoxide Hydrochloride and Clidinium Bromide — the ingredient across all brands.

Top reported reactions

Diarrhoea182
Nausea182
Fatigue167
Pain132
Headache120
Abdominal Pain112
Dizziness108

Age at onset

Adolescent3
Adult89
Elderly82

Reporter sex

1,919 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization526
Death68
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 60 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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.