Prescription medicine
Codeine and phenylephrine and promethazine
Codeine and phenylephrine and promethazine is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
- DEA Schedule V
Check it at the source: the codeine and phenylephrine and promethazine FDA label on DailyMed (effective January 8, 2026, Amneal Pharmaceuticals LLC); every codeine and phenylephrine and promethazine label on DailyMed.
Highlights of the record
FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; PROMETHAZINE AND RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID WITHDRAWAL SYNDROME.
Addiction, Abuse, and Misuse Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution 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. Assess each patient’s risk prior to prescribing Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usagePromethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older.
Forms and strengths
- 6.25 mg/5ml / 5 mg/5ml / 10 mg/5ml
Syrup.
On the market
- Generic approvals
- 7 first October 31, 1984; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
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 codeine and phenylephrine and promethazine used for?
From the label: indications and usagePromethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4) ]. […]
Conditions named in the indications of codeine and phenylephrine and promethazine's FDA labels, with every medicine labeled for each:
From other codeine and phenylephrine and promethazine labelsCough and cold: … d Codeine Phosphate Oral Solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of […]
FDA pharmacologic class: Opioid Agonist, Phenothiazine and alpha-1 Adrenergic Agonist.
Source: FDA drug label (Promethazine and Phenylephrine HCl, and Codeine Phosphate), Amneal Pharmaceuticals LLC, effective January 8, 2026 (SPL set 5f23b254-872b-4e88-91be-710c3ea7687b), via openFDA; the full label on DailyMed
What does the patient leaflet for codeine and phenylephrine and promethazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?Avoid driving a car or operating machinery during treatment with Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy, slow your thinking and motor skills, and affect your vision. Do not drink alcohol during treatment with Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution. Drinking alcohol with Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can increase your chances of having serious side effects, accidental overdose, and cause death. Avoid the use of Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution if you: are pregnant. […]
From the patient leaflet: How should I store Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?Store Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C). Store Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed container, in a dry, cool place away from heat or direct sunlight. Keep Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution and all medicines out of the reach of children.
Source: FDA drug label (Promethazine and Phenylephrine HCl, and Codeine Phosphate), Amneal Pharmaceuticals LLC, effective January 8, 2026 (SPL set 5f23b254-872b-4e88-91be-710c3ea7687b), via openFDA; the full label on DailyMed
Is there a generic for codeine and phenylephrine and promethazine?
The FDA approved the first generic codeine and phenylephrine and promethazine on October 31, 1984. 7 generic applications are approved; 2 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 codeine and phenylephrine and promethazine from 1 labeler 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.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the codeine and phenylephrine and promethazine label say about other medicines?
The codeine and phenylephrine and promethazine label names 27 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 Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in … |
| Amphetamine | drug interactions | … and Phenylephrine HCl and Codeine Phosphate Oral Solution with sympathomimetic amines such as epinephrine, amphetamine, phenylpropanolamine, and bronchodilator beta 2 -adrenoreceptor agonists may result in tachycardia, arrhythmias, serious hypertensive response and possible stroke. |
| Atomoxetine | drug interactions | … sulfate; steroids (e.g., hydrocortisone); angiotensin; aldosterone; norepinephrine transporter inhibitors (e.g., atomoxetine); and tricyclic antidepressants may enhance the pressor response and increase the risk of hypertension. |
| Atropine | drug interactions | Concomitant use may interfere with antihypertensive effects. ( 7.10 ) Ergot alkaloids, atropine sulfate, steroids, angiotensin, aldosterone, norepinephrine transporter inhibitors, and tricyclic antidepressants: |
| Bupropion | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution 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 … |
| Carbamazepine | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution 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 … |
| Cyclobenzaprine | drug interactions | Codeine may enhance the neuromuscular blocking action of skeletal muscle relaxants (e.g., cyclobenzaprine, metaxalone) and produce an increased degree of respiratory depression. |
| Epinephrine | drug interactions | … Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with sympathomimetic amines such as epinephrine, amphetamine, phenylpropanolamine, and bronchodilator beta 2 -adrenoreceptor agonists may result in tachycardia, arrhythmias, serious hypertensive response and possible stroke. |
| Erythromycin | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. … |
| Fluoxetine | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution 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 … |
| Gabapentin | drug interactions | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of … |
| Guanfacine | drug interactions | ACE inhibitors; and centrally acting sympatholytic agents (e.g., guanfacine, reserpine) may reduce their antihypertensive effects. |
| Hydrocortisone | drug interactions | Interactions that Augment the Pressor Effect of Phenylephrine The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with ergot alkaloids (e.g., methylergonovine maleate); atropine sulfate; steroids (e.g., hydrocortisone); angiotensin; aldosterone; … |
| Ketoconazole | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. … |
Every other medicine the codeine and phenylephrine and promethazine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Metaxalone | drug interactions | Codeine may enhance the neuromuscular blocking action of skeletal muscle relaxants (e.g., cyclobenzaprine, metaxalone) and produce an increased degree of respiratory depression. |
| Methylergonovine | drug interactions | … HCl and Codeine Phosphate Oral Solution with ergot alkaloids (e.g., methylergonovine maleate); atropine sulfate; steroids (e.g., hydrocortisone); angiotensin; aldosterone; … |
| Morphine | boxed warning | … the effects on the parent drug, codeine, and the active metabolite, morphine. |
| Nalmefene | warnings and precautions | … measures, and use of opioid overdose reversal agents (e.g., naloxone or nalmefene), depending on the patient’s clinical status [see Overdosage (10) ]. |
| Naloxone | warnings and precautions | … supportive measures, and use of opioid overdose reversal agents (e.g., naloxone or nalmefene), depending on the patient’s clinical status [see Overdosage (10) ]. |
| Nifedipine | drug interactions | … and beta-adrenoreceptor antagonists; calcium channel blockers (e.g., nifedipine); |
| Paroxetine | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and CYP2D6 inhibitors, such as paroxetine, fluoxetine, bupropion, or quinidine, can increase the plasma … |
| Phentolamine | drug interactions | … antihypertensive drugs, including alpha-adrenergic antagonists (e.g., phentolamine); mixed alpha- and beta-adrenoreceptor antagonists; calcium channel blockers (e.g., nifedipine); |
| Phenytoin | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels … |
| Pregabalin | drug interactions | … general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. |
| Quinidine | drug interactions | … 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 … |
| Rifampin | drug interactions | The concomitant use of Promethazine and Phenylephrine HCl and Codeine Phosphate Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels … |
| Ritonavir | drug interactions | … 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 … |
Check codeine and phenylephrine and promethazine against other medicines
Source: FDA drug label (Promethazine and Phenylephrine HCl, and Codeine Phosphate), Amneal Pharmaceuticals LLC, effective January 8, 2026 (SPL set 5f23b254-872b-4e88-91be-710c3ea7687b), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as codeine and phenylephrine and promethazine?
13 other medicines are given the same way (oral) and in the same FDA class as codeine and phenylephrine and promethazine 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 |
|---|---|---|---|---|
| Homatropine methylbromide and hydrocodone | Cough and cold | 3 labelers | $0.922 per tablet 5-1.5 mg tablet | No current entry |
| Chlorpheniramine and hydrocodone | Cough and cold | 2 labelers | $0.556 per mL Hydrocodone-chlorphen ER suspension | No current entry |
| Diphenhydramine | Cough and cold | 4 labelers | $0.0185 per mL 12.5 mg/5 mL | 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 codeine and phenylephrine and promethazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to codeine and phenylephrine and promethazine
- 13 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other