Prescription medicine
Chlordiazepoxide and clidinium Brand names: Librax
Chlordiazepoxide and clidinium (Librax) is a prescription medicine with an FDA approval on record since 1966. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.256 per chlordiazepoxide-clidinium capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the chlordiazepoxide and clidinium FDA label on DailyMed (effective January 13, 2023, Bausch Health US, LLC); the NDA 12750 record on Drugs@FDA; every chlordiazepoxide and clidinium label on DailyMed.
Highlights of the record
FDA label of January 13, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION.
and DEPENDENCE AND WITHDRAWAL REACTIONS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs 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 (see WARNINGS and PRECAUTIONS and PRECAUTIONS , Drug Interactions ).
The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Librax, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Librax and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ).
The continued use of benzodiazepines, including Librax, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageLibrax is indicated to control emotional and somatic factors in gastrointestinal disorders.
Forms and strengths
- 5 mg / 2.5 mg
Capsule.
On the market
- Earliest approval on file
- September 1, 1966 Librax, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 7, 2020; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.256 per capsule Chlordiazepoxide-clidinium capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2015 0 Class I among all firms' recalls; latest April 18, 2015
- FAERS reports
- 1,958 through July 30, 2026
What is chlordiazepoxide and clidinium used for?
From the label: indications and usageLibrax is indicated to control emotional and somatic factors in gastrointestinal disorders. Librax 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.
Conditions named in the indications of chlordiazepoxide and clidinium's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic and Benzodiazepine.
Source: FDA drug label (Librax), Bausch Health US, LLC, effective January 13, 2023 (SPL set f99ebf66-f207-4a97-9666-4da1d72b061c), via openFDA; the full label on DailyMed
What does the patient leaflet for chlordiazepoxide and clidinium say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Librax?Librax contains a benzodiazepine medicine. Taking Librax with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking Librax with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Librax, which can lead to overdose or death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Librax. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. o You can develop an addiction even if you take Librax as prescribed by your healthcare provider. o Take Librax exactly as your healthcare provider prescribed. o Do not share your Librax with other people. o Keep Librax in a safe place and away from children. • Physical dependence and withdrawal reactions. Librax can cause physical dependence and withdrawal reactions. o Do not suddenly stop using Librax. […]
From the patient leaflet: How should I store Librax?Store Librax at room temperature 77°F (25°C). • Keep Librax and all medicines out of the reach of children.
Source: FDA drug label (Librax), Bausch Health US, LLC, effective January 13, 2023 (SPL set f99ebf66-f207-4a97-9666-4da1d72b061c), via openFDA; the full label on DailyMed
Is there a generic for chlordiazepoxide and clidinium (Librax)?
The FDA approved the first generic chlordiazepoxide and clidinium on July 7, 2020. 13 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists chlordiazepoxide and clidinium from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1966 earliest approval on file
- 2020 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for chlordiazepoxide and clidinium (Librax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.256 per Chlordiazepoxide-clidinium capsule, down 16% from $0.305 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Chlordiazepoxide-clidinium capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chlordiazepoxide-clidinium capsule | Generic | $0.256 per capsule | $7.68 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has chlordiazepoxide and clidinium been recalled?
The FDA's Enforcement Report lists 2 recalls naming chlordiazepoxide and clidinium since 2015: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 18, 2015 | Class III | Valeant Pharmaceuticals North America LLC | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlordiazepoxide and clidinium label say about other medicines?
The chlordiazepoxide and clidinium label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Diazepam | drug interactions | Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of Librax after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE ). |
Check chlordiazepoxide and clidinium against other medicines
Source: FDA drug label (Librax), Bausch Health US, LLC, effective January 13, 2023 (SPL set f99ebf66-f207-4a97-9666-4da1d72b061c), via openFDA; the full label on DailyMed
What do FAERS reports show for chlordiazepoxide and clidinium?
The FDA Adverse Event Reporting System holds 1,958 reports that list chlordiazepoxide and clidinium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 532 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as chlordiazepoxide and clidinium?
4 other medicines are given the same way (oral) and in the same FDA class as chlordiazepoxide and clidinium or labeled mainly for the same use (irritable bowel syndrome), the same class first. Irritable bowel syndrome lists all 7 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dicyclomine | Irritable bowel syndrome | 37 labelers | $0.059 per tablet 20 mg tablet | No current entry |
| Tenapanor | Irritable bowel syndrome | none listed | $32.54 per tablet 50 mg tablet | No current entry |
| Linaclotide | Irritable bowel syndrome | none listed | $9.02 per capsule 145 mcg capsule | No current entry |
| Eluxadoline | Irritable bowel syndrome | none listed | $28.09 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as chlordiazepoxide and clidinium
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlordiazepoxide and clidinium
- 4 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Chlordiazepoxide and clidinium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other