Prescription medicine
Chlorpheniramine and codeine Brand names: Tuxarin; first approved as Tuxarin Er
Chlorpheniramine and codeine (Tuxarin Er) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the chlorpheniramine and codeine FDA label on DailyMed (effective January 10, 2024, Mainpointe Pharmaceuticals); the NDA 206323 record on Drugs@FDA; every chlorpheniramine and codeine label on DailyMed.
Highlights of the record
FDA label of January 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTIAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPOID WITHDRAWAL SYNDROME WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTIAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPOID WITHDRAWAL SYNDROME.
See full prescribing information for complete boxed warning. TUXARIN ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor closely for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. ( 5.2 ) Accidental ingestion of TUXARIN ER, especially by children, can result in a fatal overdose of codeine. […]
Used for
From the label: indications and usageTUXARIN ER 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
- 54.3 mg / 8 mg
Extended-release tablet.
On the market
- Earliest approval on file
- June 22, 2015 Tuxarin Er, Mainpointe; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 3, 2032 Tuxarin ER tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is chlorpheniramine and codeine used for?
From the label: indications and usageTUXARIN ER 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. TUXARIN ER is a combination of codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, 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. ( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. […]
Conditions named in the indications of chlorpheniramine and codeine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histamine-1 Receptor Antagonist and Opioid Agonist.
Source: FDA drug label (Tuxarin), Mainpointe Pharmaceuticals, effective January 10, 2024 (SPL set a7cfab67-6087-4ab4-b7cd-4f9295413180), via openFDA; the full label on DailyMed
What does the patient leaflet for chlorpheniramine and codeine 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 TUXARIN ER?TUXARIN ER is not for children under 18 years of age. TUXARIN ER can cause serious side effects, including: Addiction, abuse and misuse. Taking TUXARIN ER or other medications that contain an opioid can cause addiction, abuse, and misuse, which can lead to overdose and death. This can happen even if you take TUXARIN ER 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 TUXARIN ER with other people. Keep TUXARIN ER in a safe place away from children. Life-threatening breathing problems (respiratory depression). TUXARIN ER 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 TUXARIN ER, 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 TUXARIN ER exactly as prescribed by your healthcare provider. Call your healthcare provider or get emergency medical help right away if anyone taking TUXARIN ER has any of the symptoms below: increased sleepiness confusion difficulty breathing shallow breathing limpness Keep TUXARIN ER in a safe place away from children. Accidental use of even 1 dose of TUXARIN ER, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes TUXARIN ER, get emergency help right away. Overdose and death due to medicine dosing errors. […]
From the patient leaflet: What should I avoid doing while taking TUXARIN ER?Avoid driving a car or operating machinery during treatment with TUXARIN ER. TUXARIN ER can cause you to be drowsy, slow your thinking and motor skills, and affect your vision. Do not drink alcohol during treatment with TUXARIN ER. Drinking alcohol with TUXARIN ER can increase your chances of having serious side effects. Avoid the use of TUXARIN ER if you: are pregnant. Use of TUXARIN ER 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. Use of TUXARIN ER while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
From the patient leaflet: How should I store TUXARIN ER?Store TUXARIN ER at room temperature between 68°F to 77°F (20°C to 25°C). Keep TUXARIN ER in a tightly closed container, in a dry, cool place away from heat or direct sunlight. Keep TUXARIN ER and all medicines out of the reach of children.
Source: FDA drug label (Tuxarin), Mainpointe Pharmaceuticals, effective January 10, 2024 (SPL set a7cfab67-6087-4ab4-b7cd-4f9295413180), via openFDA; the full label on DailyMed
Is there a generic for chlorpheniramine and codeine (Tuxarin Er)?
No generic chlorpheniramine and codeine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Tuxarin ER tablets, the last expiring on January 3, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the chlorpheniramine and codeine label say about other medicines?
The chlorpheniramine and codeine label names 13 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 |
|---|---|---|
| Amiodarone | warnings and precautions | Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of TUXARIN ER with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine plasma concentration which could … |
| Bupropion | drug interactions | The concomitant use of TUXARIN ER and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [see Clinical Pharmacology (12.3) ]. |
| Carbamazepine | drug interactions | The concomitant use of TUXARIN ER and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a … |
| Erythromycin | drug interactions | The concomitant use of TUXARIN ER with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6 … |
| Fluoxetine | drug interactions | The concomitant use of TUXARIN ER and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | The concomitant use of TUXARIN ER with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6 … |
| Morphine | boxed warning | … complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. |
| Naloxone | warnings and precautions | Management of respiratory depression includes discontinuation of TUXARIN ER, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient's clinical status [ see Overdosage (10) ]. |
| Paroxetine | drug interactions | The concomitant use of TUXARIN ER and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [see Clinical Pharmacology (12.3) ]. |
| Phenytoin | drug interactions | The concomitant use of TUXARIN ER and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a … |
| Quinidine | drug interactions | The concomitant use of TUXARIN ER and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced efficacy [see Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | The concomitant use of TUXARIN ER and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a … |
| Ritonavir | drug interactions | The concomitant use of TUXARIN ER with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6 … |
Source: FDA drug label (Tuxarin), Mainpointe Pharmaceuticals, effective January 10, 2024 (SPL set a7cfab67-6087-4ab4-b7cd-4f9295413180), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as chlorpheniramine and codeine?
15 other medicines are given the same way (oral) and in the same FDA class as chlorpheniramine and codeine 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 |
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | 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 |
| Pseudoephedrine | Cough and cold | 34 labelers | $0.281 per tablet 120 mg tablet | No current entry |
Every medicine labeled for the same conditions as chlorpheniramine and codeine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlorpheniramine and codeine
- 15 medicines for the same use
- Other antihistamines
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other