Short answer: Promethazine with codeine is a prescription cough syrup that combines codeine, an opioid, with promethazine, a sedating antihistamine. It is a Schedule V controlled substance and is approved only for adults. Mixed with soda as 'lean', it can cause dangerous sedation, slowed breathing, and death, especially with alcohol or other sedatives.
Key takeaways
- What it is: Promethazine with codeine is an opioid cough suppressant with a sedating antihistamine and a Schedule V controlled substance in the US.
- Main uses: Cough and cold symptoms (adults).
- Timing: effects start in 30 to 60 minutes and last 4 to 6 hours.
- Most dangerous mix: Benzodiazepines (alprazolam, diazepam, clonazepam), which can cause profound sedation, slowed breathing, coma, death.
- Naloxone: it partly reverses an overdose (codeine only).
- Dependence risk: Moderate.
- Legal route: only with a prescription from a DEA-registered clinician, filled by a licensed pharmacy.
What is promethazine with codeine?
The syrup relieves cough and runny nose from colds and allergies in adults. In 2018 the FDA limited prescription cough and cold medicines containing codeine or hydrocodone to adults 18 and older, because risks outweigh benefits in children.
Codeine is converted to morphine by the liver enzyme CYP2D6. People who are ultra-rapid metabolizers turn it into morphine quickly and can have dangerous breathing problems at normal doses.
Quick facts
| Fact | Promethazine with codeine |
|---|---|
| Generic name | Promethazine hydrochloride and codeine phosphate oral solution |
| Strength | 6.25 mg promethazine and 10 mg codeine per 5 mL |
| Drug class | Opioid antitussive with a phenothiazine antihistamine |
| US legal status | Schedule V, prescription only |
| Approved uses | Temporary relief of cough and upper respiratory allergy or cold symptoms in adults |
| Age limit | Not for anyone under 18 (FDA, 2018) |
| Onset | 30 to 60 minutes |
| Reversal agent | Naloxone reverses codeine, not promethazine |
How long does promethazine with codeine last?
- Starts working: 30 to 60 minutes
- Effects last: 4 to 6 hours
Timing varies with the dose, the form, how it is taken, liver and kidney function, age, and other drugs taken at the same time.
What are the biggest risks of promethazine with codeine?
The FDA requires boxed warnings, its strongest, on promethazine with codeine products, including:
- Addiction, abuse, and misuse, which can lead to overdose and death.
- Life-threatening slowed breathing, especially when starting treatment or after a dose increase.
- Accidental ingestion, especially by children, can cause a fatal overdose.
- Use with benzodiazepines or other central nervous system depressants, including alcohol, can cause profound sedation, slowed breathing, coma, and death.
Common side effects include drowsiness, dizziness, constipation, nausea, dry mouth, and blurred vision.
Lean: drinking large amounts mixed with soda and candy causes deep sedation, slowed breathing, and, combined with alcohol, benzodiazepines, or other opioids, fatal overdose. Several well-known musicians have died after using it.
Promethazine risks: seizures, abnormal movements, a rare reaction called neuroleptic malignant syndrome, and severe confusion in older adults.
What should you never mix with promethazine with codeine?
| Combined with | What happens | Label guidance |
|---|---|---|
| Benzodiazepines (alprazolam, diazepam, clonazepam) | Profound sedation, slowed breathing, coma, death | Boxed warning; avoid unless no alternative |
| Alcohol | Stronger sedation and slowed breathing | Avoid |
| Gabapentin, pregabalin, sleep medicines, muscle relaxants | Additive sedation and breathing problems | Use caution; lower doses |
| Alcohol | Profound sedation and stopped breathing | Avoid |
| CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion) | Less pain and cough relief; altered codeine effects | Use caution |
| MAO inhibitors and other antipsychotics | Increased side effects; abnormal movements | Avoid |
Check any combination with the DoseUses combination checker or ask a pharmacist.
What are the signs of a promethazine with codeine overdose, and what should you do?
Overdose causes extreme drowsiness, confusion, pinpoint pupils, slow breathing, and unresponsiveness. Promethazine can add seizures, agitation, or hallucinations, which naloxone does not reverse.
If someone may have overdosed
- Call 911 if the person is unresponsive, cannot be woken, has blue or gray lips, or is breathing slowly or not at all.
- Give naloxone (Narcan or a generic nasal spray, sold without a prescription) into one nostril. If there is no response after 2 to 3 minutes, give another dose.
- If you are trained, give rescue breaths. Otherwise place the person on their side so they do not choke.
- Stay with them. Naloxone can wear off before promethazine with codeine does, so the overdose can return even after the person wakes up.
- Most states have Good Samaritan laws that protect people who call 911 for an overdose from some drug charges.
What is promethazine with codeine withdrawal like, and how long does it last?
People who take codeine syrup regularly for more than a few weeks become physically dependent, even when they take it exactly as prescribed. Dependence is not the same as addiction, but it means stopping suddenly causes withdrawal.
- 8 to 24 hoursEarly symptomsAnxiety, restlessness, yawning, sweating, runny nose, watery eyes, and muscle aches.
- Days 1 to 3Peak withdrawalDiarrhea, stomach cramps, nausea and vomiting, goosebumps, dilated pupils, fast heartbeat, and strong cravings. Rarely dangerous in healthy adults, but dehydration can be serious.
- Days 5 to 10Lingering symptomsPoor sleep, low mood, low energy, and cravings can continue for weeks. Tolerance falls quickly, which raises the risk of overdose if use restarts.
See the withdrawal timelines and the full promethazine with codeine withdrawal guide.
Is promethazine with codeine legal?
In the United States, promethazine with codeine is a Schedule V controlled substance. The only legal way to get it is with a prescription from a clinician registered with the Drug Enforcement Administration (DEA), filled by a licensed pharmacy. Depending on state law, that can be a physician, nurse practitioner, or physician assistant.
- Refills: Schedule V prescriptions can be refilled as the prescriber authorizes, subject to state law.
- Telehealth: federal flexibilities let DEA-registered clinicians prescribe Schedule II to V medicines after a telemedicine visit, without a prior in-person exam, through December 31, 2026. A permanent DEA rule was under final review in late 2026. State rules can be stricter.
- Monitoring: prescribers and pharmacists in most states check a prescription drug monitoring program, a database of controlled-substance prescriptions, before prescribing or dispensing.
Outside the United States
| Country | Status |
|---|---|
| United Kingdom | Not available as this combination; codeine linctus is pharmacy-only with restrictions |
| Australia | Codeine products prescription only since 2018 |
| International | Codeine is in Schedule II of the 1961 Single Convention; low-strength preparations are exempted in Schedule III |
Frequently asked questions about promethazine with codeine
What is lean?
A street name for promethazine with codeine syrup mixed with soda and candy. It causes heavy sedation and can be fatal, especially with alcohol.
Is promethazine with codeine a controlled substance?
Yes. It is in Schedule V, the lowest federal schedule, and requires a prescription in almost every state.
Can children take codeine cough syrup?
No. Since 2018 the FDA limits prescription codeine cough and cold medicines to adults 18 and older.
Can you get addicted to codeine cough syrup?
Yes. Regular use, especially at high doses, can cause dependence, withdrawal, and addiction.
Does naloxone work on lean?
It reverses the codeine, but not the sedation from promethazine or alcohol. Call 911 and give naloxone anyway.
Sources
- FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products, US Food and Drug Administration, January 2018.
- promethazine and codeine prescribing information, DailyMed, US National Library of Medicine.
- FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines, US Food and Drug Administration, 2016.
- Information about naloxone and nalmefene, US Food and Drug Administration.
- CDC Clinical Practice Guideline for Prescribing Opioids for Pain, 2022, Centers for Disease Control and Prevention, MMWR.
- Controlled Substance Schedules, DEA Diversion Control Division.
- Prescribing controlled substances via telehealth, US Department of Health and Human Services.
- BeSafeRx: Your Source for Online Pharmacy Information, US Food and Drug Administration.
This guide summarizes the sourced DoseUses Promethazine with codeine profile, written from FDA labels, DEA rules, and federal health agencies. It is educational and is not medical advice. Last updated October 5, 2026.
