Triprolidine, pseudoephedrine, and codeine (Oral)

Triprolidine, pseudoephedrine, and codeine combination is used to relieve cough, sneezing, itchy or runny nose, and nasal congestion (stuffy nose) caused by allergies or the common cold.

Triprolidine is an antihistamine that works by blocking the effects of a substance called histamine, which the body produces. Histamine can cause itching, sneezing, runny nose, and watery eyes. Pseudoephedrine is a decongestant that helps decrease nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage. Codeine is a narcotic antitussive (cough suppressant) that works directly on the cough center in the brain to relieve cough.

When codeine is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing cough and nasal congestion should not let the fear of dependence prevent them from using narcotics to relieve their cough. Mental dependence (addiction) is unlikely to happen when narcotics are used for this reason. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

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

It is very important for your doctor to monitor your progress while you are using this medicine. This helps your doctor determine if the medicine is effective and if you should keep using it. If your symptoms do not improve or worsen, call your doctor.

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

If you think you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Symptoms of an overdose include extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin.

This medicine may cause dizziness or drowsiness. Do not drive or do anything else until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medicines with triprolidine, pseudoephedrine, and codeine may increase the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of CNS-affecting medicines include antihistamines or allergy or cold medications, sedatives, tranquilizers, or sleeping medicines, medications for depression, anxiety, prescription pain medicines or narcotics, medications for attention deficit and hyperactivity disorder, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Codeine is converted to morphine in the body. Some people convert codeine to morphine more quickly than others; these individuals are called "ultra-rapid metabolizers of codeine." Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may mean that you are an "ultra-rapid metabolizer of codeine," leading to too much morphine in the body and more side effects than usual. Children may be especially sensitive to this effect. Do not give this medicine to children with obstructive sleep apnea (breathing problem) who have had surgery to remove tonsils or adenoids.

If a nursing mother is an ultra-rapid metabolizer of codeine, it could result in a 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 taking codeine or 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 (e.g., "call 9-1-1") right away 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.

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.

In deciding to use a drug, the risks of taking the drug 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

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medications. Also inform 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triprolidine, pseudoephedrine, and codeine combination in children.

Triprolidine, pseudoephedrine, and codeine combination should not be used to relieve pain following surgery removal of tonsils or adenoids in children. Severe breathing issues 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 triprolidine, pseudoephedrine, and codeine combination in the elderly.

Breast Feeding

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.

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

Studies in women suggest that this drug poses minimal chance to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medications 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 clinician may want to change the dose, or other precautions may be necessary. When you are using this medicine, it is especially essential 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 drugs is not advised. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Toloxatone
• Tranylcypromine

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

• Abametapir
• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Amantadine
• Amifampridine
• Amiloride
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Apalutamide
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Asenapine
• Atazanavir
• Atropine
• Baclofen
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Benztropine
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bumetanide
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopamide
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclosporine
• Cyclothiazide
• Cyproheptadine
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Eplerenone
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethacrynic Acid
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etozolin
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indapamide
• Indinavir
• Iobenguane I 123
• Iobenguane I 131
• Ipratropium
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Larotrectinib
• Lasmiditan
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyclothiazide
• Methyldopa
• Metoclopramide
• Metolazone
• Mibefradil
• Midazolam
• Midodrine
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piretanide
• Piritramide
• Pitolisant
• Polythiazide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Spironolactone
• St John's Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Torsemide
• Tramadol
• Trazodone
• Triamterene
• Triazolam
• Trichlormethiazide
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Tropicamide
• Trospium
• Tryptophan
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Xipamide
• Zaleplon
• Zavegepant
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drugs may additionally 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 medication 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 frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Asthma or
• Breathing issues (eg, obstructive sleep apnea) or
• Heart or blood vessel disease, serious or
• Hypertension (high blood pressure), serious or
• Surgery (eg, surgical removal of adenoid or tonsil), history of—Should not be used in patients with these conditions.

• Asthma, history of or
• Brain issues (eg, tumor, increased pressure in the head), history of or
• Diabetes or
• Drug dependence, especially with narcotic abuse or dependence, or history of or
• Enlarged prostate or
• Gallbladder issues or
• Glaucoma or history of or
• Head injury, history of or
• Heart disease or
• Heart rhythm problems or
• Hyperthyroidism (overactive thyroid) or
• Issues with passing urine or history of or
• Stomach or bowel issues (eg, ulcers, blockage)—Use with caution. May increase risk for more severe side effects.

• Kidney disease, serious or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

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

Incidence not known

• Anxiety
• Back, leg, or stomach pain
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Blurred vision
• Cold, clammy skin
• Confusion
• Cough
• Dark urine
• Decrease in how much or how often you urinate
• Difficulty breathing
• Difficulty sleeping
• Difficulty urinating
• Disturbed coordination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Double vision
• Drowsiness to profound loss of consciousness
• Excessive sweating and chills
• Excitation
• False or unusual sense of well-being
• Fast, irregular, pounding, or racing heartbeat or pulse
• Feeling of constant movement of self or surroundings
• Fever with or without chills
• General body swelling
• General feeling of tiredness or weakness
• Headache
• Hoarseness
• Irritability
• Loss of appetite
• Lower back or side pain
• Mood or other mental changes
• Nausea
• Nervousness
• Nosebleed
• Painful or difficult urination
• Pinpoint red spots on the skin
• Relaxed and calm feeling
• Restlessness
• Seeing double
• Seeing, hearing, or feeling things that are not there
• Seizures
• Sensation of spinning
• Sleepiness
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stuffy nose
• Thickening of bronchial secretions
• Tightness of the chest
• Tremor
• Unusual bleeding or bruising
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Vomiting
• Yellowing of the 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. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Dry mouth, throat, or nose
• Increased sensitivity of the skin to sunlight
• Itching, skin rash
• Redness or other discoloration of the skin
• Severe sunburn

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.

Pharmacologic Class: Antihistamine

Chemical Class: Alkylamine

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. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

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 oral dosage form (syrup):For relief of cough, sneezing, or runny or stuffy nose: Adults and children 12 years of age and older—10 milliliters (mL) every 4 to 6 hours. Do not take more than 4 doses (40 mL) in 24 hours. Children 6 to 11 years of age—5 mL every 4 to 6 hours. Do not take more than 4 doses (20 mL) in 24 hours. Children 2 to 5 years of age—2.5 mL every 4 to 6 hours. Do not take more than 4 doses (10 mL). Children younger than 2 years of age—Use and dose must be determined by your doctor.

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 website 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