Promethazine with codeine at a glance: schedule, half-life, and class
- 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
Promethazine with codeine uses: what it is used for
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.[1]
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.[2]
Promethazine with codeine dosage: how it is usually prescribed
The figures below come from the FDA-approved label and describe how prescribers typically use promethazine with codeine. They are not personal dosing advice. A prescriber sets the dose for each person and adjusts it over time.[2]
| Product | Typical adult dose | Notes from the label |
|---|---|---|
| Adults | 5 mL every 4 to 6 hours as needed | No more than 30 mL in 24 hours |
| Under 18 | Do not use | FDA restriction since 2018 |
| Older adults | Lower doses | More sensitive to sedation and confusion |
Promethazine with codeine side effects and risks
FDA boxed warnings
- 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.[3]
- Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
- Promethazine can cause fatal slowed breathing in children under 2 and should not be used in this age group.
- Ultra-rapid CYP2D6 metabolizers can have life-threatening breathing problems from codeine.
Common side effects include drowsiness, dizziness, constipation, nausea, dry mouth, and blurred vision.[2]
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.[2]
Promethazine with codeine interactions: what not to mix with it
Choose what it would be combined with:
| 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 |
This is not a full list. A pharmacist can check a complete medication list, including supplements and over-the-counter products.[2]
Promethazine with codeine overdose: signs and what to do
Overdose causes extreme drowsiness, confusion, pinpoint pupils, slow breathing, and unresponsiveness. Promethazine can add seizures, agitation, or hallucinations, which naloxone does not reverse.[2][4]
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.
Promethazine with codeine withdrawal timeline: symptoms and how long it lasts
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.[2]
- 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.
Warning: After a break, the body loses tolerance within days. Returning to a previous dose of codeine syrup can cause a fatal overdose.
The FDA warns against stopping opioids abruptly in people who are physically dependent. A prescriber can taper the dose gradually, often by 10% or less per month for long-term users, and medicines such as clonidine or lofexidine can ease symptoms. For opioid use disorder, buprenorphine and methadone cut the risk of death roughly in half.[5]
How to get prescribed promethazine with codeine legally in the US
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.[6]
- Refills: Schedule V prescriptions can be refilled as the prescriber authorizes, subject to state law.[6]
- 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.[7]
- Monitoring: prescribers and pharmacists in most states check a prescription drug monitoring program, a database of controlled-substance prescriptions, before prescribing or dispensing.
- Pharmacies: a legitimate pharmacy always requires a valid prescription, has a licensed pharmacist available, and is licensed in the state it ships to. The FDA's BeSafeRx tool and the NABP's safe pharmacy list help confirm a pharmacy is real.[8][9]
- Cost: generic promethazine with codeine syrup is inexpensive, but many pharmacies stock little of it and dispense limited amounts.
- State rules: federal law allows some Schedule V cough syrups to be sold without a prescription under strict limits, but almost all states and most pharmacies now require a prescription.
Traveling: keep the medicine in its original pharmacy container and carry a copy of the prescription. Check the rules of the destination country before travel, because many countries restrict controlled medicines or require a permit.
Can you order promethazine with codeine online legally?
Yes, but only with a valid prescription and only from a pharmacy licensed in your state. Many licensed pharmacies, including mail-order pharmacies run by insurers, fill promethazine with codeine prescriptions online and ship them. Buying promethazine with codeine from a website that does not require a prescription is illegal, and the product is often fake.[8][10]
- See a licensed clinicianA clinician evaluates you in person or by telemedicine and decides whether promethazine with codeine is appropriate.
- The prescription goes to a pharmacyPrescriptions are usually sent electronically, straight from the prescriber to the pharmacy you choose.
- The pharmacy checks and fills itA pharmacist verifies the prescription and your identity, then dispenses the medicine in person or by mail.
Signs that an online seller is illegal:
- It sells promethazine with codeine with no prescription, or after only a short online questionnaire.
- It takes orders through social media, messaging apps, or email.
- It asks for payment in cryptocurrency, gift cards, or money transfers.
- It has no US street address, no state pharmacy license, and no pharmacist to speak to.
- Its prices are far below those of ordinary pharmacies, or it ships from another country.
The FDA's BeSafeRx tool links to each state's license lookup, and the National Association of Boards of Pharmacy lists verified online pharmacies.[8][9]
Promethazine with codeine price: how much does promethazine with codeine cost without insurance?
Generic promethazine with codeine syrup is inexpensive, but many pharmacies stock little of it and dispense limited amounts.
What you pay depends on the strength, the number of doses, your insurance plan, and the pharmacy. Cash prices for the same prescription can differ several times over between pharmacies in the same town, so check current prices before you fill it.
Ways to pay less, legally:
- Ask the prescriber whether a generic promethazine with codeine is available. FDA-approved generics work the same way as the brand and usually cost much less.
- Compare cash prices between pharmacies before you fill the prescription.
- Use a free prescription discount card, such as GoodRx or SingleCare, when you pay cash. These cards cannot be combined with insurance on the same fill.
- For brand-name medicines, check the manufacturer's savings program or patient assistance program.
- Ask about a 90-day supply or your insurer's mail-order pharmacy, which often lowers the cost per dose when your prescriber agrees it is appropriate.
Warning: A price far below what licensed pharmacies charge, especially with no prescription required, is a strong sign of an illegal seller and counterfeit medicine.[8]
Promethazine with codeine legal status in other countries
| 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 |
Laws change and differ in detail. Check current rules before carrying any controlled medicine across a border.[11]
Common 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.
Can you buy promethazine with codeine without a prescription?
No. promethazine with codeine is a Schedule V controlled substance in the US, so it is illegal to buy or possess it without a valid prescription. Websites and social media sellers that offer it without one are not legal pharmacies, and the DEA warns that pills sold this way are often counterfeit and can contain fentanyl. The legal route is a visit with a licensed clinician, in person or by telehealth, and a prescription filled at a state-licensed pharmacy. The FDA's BeSafeRx tool and the NABP's safe pharmacy list help confirm an online pharmacy is real.
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.
- Safe Pharmacy. National Association of Boards of Pharmacy.
- One Pill Can Kill. US Drug Enforcement Administration.
- International drug control conventions. United Nations Office on Drugs and Crime.
