Quick answers
- What is Codeine phosphate and chlorpheniramine maleate used for?
- The FDA-approved label (Tuxarin, Mainpointe Pharmaceuticals, January 10, 2024) says: “TUXARIN 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Codeine phosphate and chlorpheniramine maleate?
- The “Adverse Reactions” section of the FDA label (Tuxarin, Mainpointe Pharmaceuticals, January 10, 2024) begins: “The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5, 5.9), Overdosage (10)] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [see Warnings and Precautions (5.3)] Accidental …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Codeine phosphate and chlorpheniramine maleate?
- The “Drug Interactions” section of the FDA label (Tuxarin, Mainpointe Pharmaceuticals, January 10, 2024) begins: “No specific drug interaction studies have been conducted with TUXARIN ER. Phenytoin: Avoid concomitant use; may increase phenytoin levels. (7.4) Serotonergic drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.6) Muscle relaxants: Avoid concomitant use. (7.8) Diuretics: Codeine may reduce the efficacy of diuretics. Monitor for reduced effect. (7.9) Anticholinergic drugs: Concurrent use may cause paralytic ileus.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Codeine phosphate and chlorpheniramine maleate have a boxed warning?
- Yes. The FDA label for Tuxarin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Codeine phosphate and chlorpheniramine maleate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Codeine phosphate and chlorpheniramine maleate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Codeine phosphate and chlorpheniramine maleate?
- 1 company lists prescription products of Codeine phosphate and chlorpheniramine maleate in the FDA NDC Directory, including Mainpointe Pharmaceuticals.
What Codeine phosphate and chlorpheniramine maleate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TUXARIN 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 …
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, extended release, oral), Tuxarin, Mainpointe Pharmaceuticals; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Codeine phosphate and chlorpheniramine maleate boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
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 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.
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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. (5.2) Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. (5.3) TUXARIN ER is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (4) Avoid the use of TUXARIN ER in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Ensure accuracy when prescribing, dispensing, and administering TUXARIN ER. Dosing errors can result in accidental overdose and death. (2.1, 5.6) The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of TUXARIN ER in these patients. (5.4, 7.1, 7.2, 7.4) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of TUXARIN ER in patients taking benzodiazepines, other CNS depressants, or alcohol. (5.9, 7.5) TUXARIN ER is not recommended for use in pregnant women. Prolonged use of TUXARIN ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If TUXARIN ER is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.15, 8.1) Addiction, Abuse, and Misuse TUXARIN ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve TUXARIN ER 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.
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. This is part of the section. Read the full label on DailyMed →
Codeine phosphate and chlorpheniramine maleate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5, 5.9), Overdosage (10)] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [see Warnings and Precautions (5.3)] Accidental …
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. This is part of the section. Read the full label on DailyMed →
Codeine phosphate and chlorpheniramine maleate drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
No specific drug interaction studies have been conducted with TUXARIN ER. Phenytoin: Avoid concomitant use; may increase phenytoin levels. (7.4) Serotonergic drugs: Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.6) Muscle relaxants: Avoid concomitant use. (7.8) Diuretics: Codeine may reduce the efficacy of diuretics. Monitor for reduced effect. (7.9) Anticholinergic drugs: Concurrent use may cause paralytic ileus.
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(5.10, 7.10) 7.1 Inhibitors of CYP3A4 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, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of TUXARIN ER is achieved [see Warnings and Precautions (5.8)]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. Avoid the use of TUXARIN ER while taking a CYP3A4 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. 7.2 CYP3A4 Inducers 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 withdrawal syndrome in patients who have developed physical dependence [see Warnings and Precautions (5.8)]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Avoid the use of TUXARIN ER in patients who are taking CYP3A4 inducers. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy. 7.3 Phenytoin Adverse event reports in the literature suggest a possible drug interaction involving increased serum phenytoin levels and phenytoin toxicity when chlorpheniramine and phenytoin are co-administered. The exact mechanism for this interaction is not known, however it is believed that chlorpheniramine may inhibit the hepatic metabolism of phenytoin. Avoid the use of TUXARIN ER while taking phenytoin. 7.4 Inhibitors of CYP2D6 Codeine is metabolized by CYP2D6 to form morphine.
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. This is part of the section. Read the full label on DailyMed →
Codeine phosphate and chlorpheniramine maleate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Adults 18 years of age and older: 1 tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. (2.2) Do not increase the dose or dosing frequency. (2.1) Prescribe for the shortest duration consistent with treatment goals. (2.3) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. (2.3) Reevaluate patient prior to refilling.
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(2.3) 2.1 Important Dosage and Administration Instructions Administer TUXARIN ER by the oral route only. Advise patients not to increase the dose or dosing frequency of TUXARIN ER because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2), Overdosage (10)]. The dosage of TUXARIN ER should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [see Dosage and Administration (2.3), Warnings and Precautions (5.5)]. 2.2 Recommended Dosage Adults 18 years of age and older: one tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. 2.3 Monitoring, Maintenance, and Discontinuation of Therapy Prescribe TUXARIN ER for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions (5.1)] Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [see Warnings and Precautions (5.2)]. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions (5.5)]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with TUXARIN ER, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Do not abruptly discontinue TUXARIN ER in a physically-dependent patient [see Drug Abuse and Dependence (9.3)]. When a patient who has been taking TUXARIN ER regularly and may be physically dependent no longer requires therapy with TUXARIN ER, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. Read the full label on DailyMed →
Codeine phosphate and chlorpheniramine maleate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary TUXARIN ER is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.15) and Clinical Considerations]. There are no available data with TUXARIN ER use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
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Published studies with codeine have reported inconsistent findings and have important methodological limitations (see Data). There are reports of respiratory depression when codeine is used during labor and delivery (see Clinical Considerations). Reproductive toxicity studies have not been conducted with TUXARIN ER; however, studies are available with individual active ingredients (see Data). In animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 15 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity (see Data). Chlorpheniramine administered by the oral route to mice throughout pregnancy was embryolethal at a dose approximately 9 times the MRHD and decreased postnatal survival when dosing was continued after parturition. Chlorpheniramine administered by the oral route to male and female rats prior to mating produced embryolethality at a dose approximately 9 times the MRHD (see Data). Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.15)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Opioids, including TUXARIN ER, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions.
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. This is part of the section. Read the full label on DailyMed →
When Codeine phosphate and chlorpheniramine maleate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
TUXARIN ER is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.4)]. Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.2, 5.3)].
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TUXARIN ER is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.10)]. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days [see Warnings and Precautions (5.13), Drug Interactions (7.7)]. Hypersensitivity to codeine, chlorpheniramine, or any of the inactive ingredients in TUXARIN ER [see Adverse Reactions (6)]. Persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. Children younger than 12 years of age (4) Significant respiratory depression. (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4) Known or suspected gastrointestinal obstruction, including paralytic ileus. (4) Concurrent use of monoamine oxidase inhibitor (MAOI) therapy or within the last 14 days. (4) Hypersensitivity to codeine or other opiates, chlorpheniramine, or any of the inactive ingredients in TUXARIN ER. (4)
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. Read the full label on DailyMed →
Codeine phosphate and chlorpheniramine maleate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Clinical Presentation Codeine Acute overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, hypoglycemia, circulatory collapse, cardiac arrest, and death.
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Codeine may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)]. Chlorpheniramine Signs and symptoms of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucinations, gastrointestinal symptoms, convulsions, urinary retention, cardiac arrhythmias and coma) may be observed. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of TUXARIN ER together with institution of appropriate therapy. Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. Gastric emptying may be useful in removing unabsorbed drug. The opioid antagonists, naloxone and nalmefene, are specific antidotes for respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to codeine overdose, administer an opioid antagonist. An antagonist should not be administered in the absence of clinically significant respiratory depression. Because the duration of opioid reversal is expected to be less than the duration of action of codeine in TUXARIN ER, carefully monitor the patient until spontaneous respiration is reliably reestablished. TUXARIN ER will continue to release codeine and add to the codeine load for 4 hours or longer following ingestion, necessitating prolonged monitoring.
— FDA label: Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024. This is part of the section. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tuxarin |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mainpointe Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206323 TUXARIN ER | Mainpointe | June 22, 2015 | 6, latest July 10, 2026 2026: Labeling · 2023: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1664543, 2099286 |
|---|---|
| SPL set ID of the quoted label | a7cfab67-6087-4ab4-b7cd-4f9295413180 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206323 |
| Active ingredients (FDA) | CHLORPHENIRAMINE / CODEINE |
Next steps
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tuxarin, Mainpointe Pharmaceuticals, effective January 10, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →