Prescription medicine
Chlorpheniramine and hydrocodone First approved as Vituz
Chlorpheniramine and hydrocodone (Vituz) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $0.556 per mL (Hydrocodone-chlorphen ER suspension) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the chlorpheniramine and hydrocodone FDA label on DailyMed (effective June 26, 2025); the NDA 204307 record on Drugs@FDA; every chlorpheniramine and hydrocodone label on DailyMed.
Highlights of the record
FDA label of June 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME.
Addiction, Abuse, and Misuse Hydrocodone Polistirex and Chlorpheniramine Polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. […]
Used for
From the label: indications and usageHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Forms and strengths
- 10 mg/5ml / 8 mg/5ml
Extended-release suspension.
On the market
- Earliest approval on file
- February 20, 2013 Vituz, Persion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 27, 2015; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.556 per mL Hydrocodone-chlorphen ER suspension
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest July 11, 2019
- FAERS reports
- 976 through July 30, 2026
What is chlorpheniramine and hydrocodone used for?
From the label: indications and usageHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations (8.4 ) ].
Contraindicated in pediatric patients less than 6 years of age [ see Contraindications (4) ]. […]
Conditions named in the indications of chlorpheniramine and hydrocodone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histamine-1 Receptor Antagonist and Opioid Agonist.
Source: FDA drug label (Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release), Bryant Ranch Prepack, effective June 26, 2025 (SPL set e0010aac-2d7e-4dd3-8024-ff0c7f668b77), via openFDA; the full label on DailyMed
What does the patient leaflet for chlorpheniramine and hydrocodone 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 Hydrocodone Polistirex and Chlorpheniramine Polistirex?Hydrocodone Polistirex and Chlorpheniramine Polistirex is not for children under 18 years of age. Hydrocodone Polistirex and Chlorpheniramine Polistirex can cause serious side effects, including: Addiction, abuse and misuse. Taking Hydrocodone Polistirex and Chlorpheniramine Polistirex or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take Hydrocodone Polistirex and Chlorpheniramine Polistirex exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems. Do not share your Hydrocodone Polistirex and Chlorpheniramine Polistirex with other people. Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex in a safe place away from children. Life-threatening breathing problems (respiratory depression). Hydrocodone Polistirex and Chlorpheniramine Polistirex can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking Hydrocodone Polistirex and Chlorpheniramine Polistirex, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take Hydrocodone Polistirex and Chlorpheniramine Polistirex exactly as prescribed by your healthcare provider. […]
From the patient leaflet: What should I avoid while taking Hydrocodone Polistirex and Chlorpheniramine Polistirex?Avoid driving a car or operating machinery during treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex. Hydrocodone Polistirex and Chlorpheniramine Polistirex can cause you to be drowsy, slow your thinking and motor skills, and may affect your vision. Do not drink alcohol during treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex. Drinking alcohol can increase your chances of having serious side effects. Avoid the use of Hydrocodone Polistirex and Chlorpheniramine Polistirex if you: are pregnant. Use of Hydrocodone Polistirex and Chlorpheniramine Polistirex during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant. are breastfeeding. […]
From the patient leaflet: How should I store Hydrocodone Polistirex and Chlorpheniramine Polistirex?Store Hydrocodone Polistirex and Chlorpheniramine Polistirex at room temperature between 68°F to 77°F (20°C to 25°C). Store Hydrocodone Polistirex and Chlorpheniramine Polistirex in a tightly closed container, in a dry, cool place away from heat or direct sunlight. Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension and all medicines out of the reach of children.
Source: FDA drug label (Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release), Bryant Ranch Prepack, effective June 26, 2025 (SPL set e0010aac-2d7e-4dd3-8024-ff0c7f668b77), via openFDA; the full label on DailyMed
Is there a generic for chlorpheniramine and hydrocodone (Vituz)?
The FDA approved the first generic chlorpheniramine and hydrocodone on January 27, 2015. 2 generic applications are approved; 0 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 chlorpheniramine and hydrocodone from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2013 earliest approval on file
- 2015 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 chlorpheniramine and hydrocodone (Vituz)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.556 per mL (Hydrocodone-chlorphen ER suspension), up 30% from $0.429 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.
- Hydrocodone-chlorphen ER suspension (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydrocodone-chlorphen ER suspension | Generic | $0.556 per mL | n/a | +30% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has chlorpheniramine and hydrocodone been recalled?
The FDA's Enforcement Report lists 1 recall naming chlorpheniramine and hydrocodone since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 11, 2019 | Class II | Tris Pharma Inc. | Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlorpheniramine and hydrocodone label say about other medicines?
The chlorpheniramine and hydrocodone label names 7 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 |
|---|---|---|
| Carbamazepine | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Erythromycin | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
| Ketoconazole | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
| Naloxone | warnings and precautions | Management of respiratory depression includes discontinuation of Hydrocodone Polistirex and Chlorpheniramine Polistirex, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [ see Overdosage (10) ]. |
| Phenytoin | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Rifampin | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who … |
| Ritonavir | drug interactions | The concomitant use of Hydrocodone Polistirex and Chlorpheniramine Polistirex and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or … |
Check chlorpheniramine and hydrocodone against other medicines
Source: FDA drug label (Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release), Bryant Ranch Prepack, effective June 26, 2025 (SPL set e0010aac-2d7e-4dd3-8024-ff0c7f668b77), via openFDA; the full label on DailyMed
What do FAERS reports show for chlorpheniramine and hydrocodone?
The FDA Adverse Event Reporting System holds 976 reports that list chlorpheniramine and hydrocodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 196 are coded as a death and 12 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 chlorpheniramine and hydrocodone?
16 other medicines are given the same way (oral) and in the same FDA class as chlorpheniramine and hydrocodone or labeled mainly for the same use (cough and cold), the same class first. Cough and cold lists all 31 medicines labeled for it, by any route. The first 8 are below. 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 |
|---|---|---|---|---|
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | No current entry |
| Fexofenadine and pseudoephedrine | Cough and cold | 27 labelers | $0.483 per tablet 60-120 tablet | No current entry |
| Codeine and promethazine | Cough and cold | 5 labelers | $0.0697 per mL Promethazine-codeine solution | No current entry |
| Codeine and phenylephrine and promethazine | Cough and cold | 1 labeler | n/a | No current entry |
| Dextromethorphan and guaifenesin | Cough and cold | 61 labelers | $0.0207 per mL 200-20 mg/20 mL | No current entry |
| Guaifenesin | Cough and cold | 102 labelers | $0.284 per tablet 600 mg tablet | No current entry |
| Benzonatate | Cough and cold | 45 labelers | $0.0656 per capsule 100 mg capsule | No current entry |
| Dextromethorphan | Cough and cold | 28 labelers | $0.122 per unit 15 mg softgel | No current entry |
Every medicine labeled for the same conditions as chlorpheniramine and hydrocodone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlorpheniramine and hydrocodone
- 16 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Chlorpheniramine and hydrocodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other