Codeine, Phenylephrine, And Promethazine (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Promethazine VC With Codeine

Descriptions

Codeine, phenylephrine, and promethazine combination is used for the temporary relief of cough, runny or stuffy nose, sneezing, or other symptoms caused by allergies or the common cold.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. Phenylephrine is a decongestant. It works by narrowing the blood vessels and leads to the clearing of nasal congestion.

Promethazine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult.

When codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Elixir
Syrup

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of Promethazine VC with codeine oral liquid in children and Promethazine, phenylephrine, and codeine oral solution in children younger than 12 years of age is not recommended.

It should not be used to relieve pain after surgery to remove tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of codeine, phenylephrine, and promethazine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving codeine, phenylephrine, and promethazine combination.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Bromopride
Calcium Oxybate
Cisapride
Dihydroergotamine
Dronedarone
Furazolidone
Iproniazid
Isocarboxazid
Levoketoconazole
Linezolid
Magnesium Oxybate
Mesoridazine
Methylene Blue
Moclobemide
Nalmefene
Naltrexone
Nialamide
Ozanimod
Phenelzine
Pimozide
Piperaquine
Potassium Citrate
Potassium Oxybate
Procarbazine
Rasagiline
Safinamide
Samidorphan
Saquinavir
Selegiline
Sodium Oxybate
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Abiraterone Acetate
Acepromazine
Aclidinium
Adagrasib
Alfentanil
Alfuzosin
Almotriptan
Alosetron
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anagrelide
Anileridine
Apalutamide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Atropine
Azithromycin
Baclofen
Belladonna
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Buprenorphine
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Clothiapine
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabrafenib
Daridorexant
Darifenacin
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Delorazepam
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicyclomine
Difenoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Efavirenz
Elagolix
Eletriptan
Encorafenib
Enflurane
Entrectinib
Enzalutamide
Epinephrine
Eplerenone
Ergonovine
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etrasimod
Etravirine
Fedratinib
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Fingolimod
Flavoxate
Flecainide
Flibanserin
Fluconazole
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fospropofol
Fostemsavir
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Glucagon
Glycopyrrolate
Glycopyrronium Tosylate
Gonadorelin
Goserelin
Granisetron
Halazepam
Halofantrine
Haloperidol
Halothane
Hexobarbital
Histrelin
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indapamide
Indinavir
Inotuzumab Ozogamicin
Iobenguane I 123
Iobenguane I 131
Ipratropium
Isoflurane
Isradipine
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lacosamide
Lapatinib
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lenvatinib
Letermovir
LetibotulinumtoxinA-wlbg
Leuprolide
Levocetirizine
Levofloxacin
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Lumefantrine
Macimorelin
Magnesium Oxybate
Mavacamten
Meclizine
Medazepam
Mefloquine
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Methacholine
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Methylergonovine
Metoclopramide
Metolazone
Metrizamide
Metronidazole
Mibefradil
Midazolam
Midodrine
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Mobocertinib
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nafcillin
Nalbuphine
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nordazepam
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Osilodrostat
Osimertinib
Oxaliplatin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Palbociclib
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Pitolisant
Polythiazide
Ponesimod
Porfimer
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procainamide
Procarbazine
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propafenone
Propantheline
Propiverine
Propofol
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Quizartinib
Ramelteon
Ranitidine
Ranolazine
Relugolix
Remifentanil
Remimazolam
Remoxipride
Revefenacin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rizatriptan
Rolapitant
Ropeginterferon Alfa-2b-njft
Saquinavir
Scopolamine
Secobarbital
Secretin Human
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Spironolactone
St John's Wort
Stramonium
Sufentanil
Sulpiride
Sumatriptan
Sunitinib
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telavancin
Telithromycin
Temazepam
Terbinafine
Terodiline
Tetrabenazine
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Toremifene
Torsemide
Tramadol
Trazodone
Triamterene
Triazolam
Trichlormethiazide
Triclabendazole
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Triptorelin
Tropicamide
Trospium
Tryptophan
Umeclidinium
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vortioxetine
Voxelotor
Xipamide
Zaleplon
Zavegepant
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aminolevulinic Acid
Belladonna
Belladonna Alkaloids
Betel Nut
Evening Primrose
Midodrine
Phenylalanine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For symptoms of cough or stuffy nose caused by allergies:
- For oral dosage forms (elixir or syrup):
  - Adults—5 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 30 mL in 24 hours.
  - Children—Use is not recommended.
- For oral dosage form (syrup):
  - Adults and children 12 years of age and older—5 milliliters (mL) or 1 teaspoonful every 4 to 6 hours. Do not take more than 30 mL in 24 hours.
  - Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions

It is very important that your doctor check your or your child's progress while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms (eg, cough) do not improve or become worse within 5 days, check with your doctor right away.

Do not use this medicine if you or your child is using or has used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you have extreme drowsiness, sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

Children younger than 12 years of age.
Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

Talk to your doctor if you have any questions about using codeine or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you or your child are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives or stool softeners, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may make you dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

Promethazine may increase your risk for convulsions (seizures). It may also cause dystonia (movement disorder). This is more likely in sick children with diarrhea. Talk to your doctor if you have any concerns.

Check with your doctor right away if you or your child are having convulsions, difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You or your child may need to stop using this medicine several days before you have surgery or medical tests.

This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools
bleeding gums
bloating
blood in the urine or stools
blurred vision
chest pain
chills
clay-colored stools
cold sweats
confusion
constipation
cough
dark urine
decrease in the frequency of urination
decrease in urine volume
difficult or troubled breathing
difficulty in passing urine (dribbling)
dizziness
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
fainting
fast or slow, pounding, or irregular heartbeat or pulse
fever
headache
high fever
increased sweating
irregular, fast or slow, or shallow breathing
lightheadedness
loss of appetite
loss of bladder control
nausea
nervousness
painful or difficult urination
pale or blue lips, fingernails, or skin
pinpoint red spots on the skin
pounding in the ears
rash or itching
seizures
severe muscle stiffness
shakiness in the legs, arms, hands, or feet
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain
swollen glands
tiredness
trembling or shaking of the hands or feet
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
unusually pale skin
vomiting
vomiting of blood
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

Incidence not known

Anxiety
blurred or loss of vision
confusion about identity, place, and time
disturbed color perception
double vision
dry mouth
false or unusual sense of well-being
halos around lights
increased sensitivity of the skin to sunlight
night blindness
overbright appearance of lights
redness or other discoloration of the skin
relaxed and calm feeling
restlessness
seeing, hearing, or feeling things that are not there
severe sunburn
sleepiness or unusual drowsiness
trouble sleeping
tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/codeine-phenylephrine-and-promethazine-oral-route/description/drg-20095217

Codeine, Phenylephrine, And Promethazine (Oral Route)

Description and Brand Names

US Brand Name

Descriptions

Before Using

Allergies

Pediatric

Geriatric

Breastfeeding

Drug Interactions

Other Interactions

Other Medical Problems

Proper Use

Dosing

Missed Dose

Storage

Precautions

Side Effects

Incidence not known

More common

Incidence not known

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