Hydron PSC (Oral)

Hydrocodone, chlorpheniramine, and pseudoephedrine combination is used to relieve cough and nasal congestion caused by the common cold or allergies.

Hydrocodone is a narcotic antitussive (cough suppressant) that works directly on the cough center in the brain to stop coughing. Chlorpheniramine is an antihistamine that helps relieve or prevent allergy symptoms. Pseudoephedrine is a decongestant that reduces nasal congestion by narrowing blood vessels and decreasing blood flow to the nasal passages.

Using hydrocodone for a long time may lead to habit formation, causing mental or physical dependence. However, individuals with ongoing cough and nasal congestion should not avoid using narcotics for relief out of fear of dependence. It is unlikely to develop mental dependence (addiction) when narcotics are used for this reason. Physical dependence could cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by slowly decreasing 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 check your progress while you are taking this medicine. This helps your doctor see if the medicine is working properly and decide if you should keep taking it. If your cough does not get better or gets worse within 5 days, call your doctor.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) like Eldepryl®, Marplan®, Nardil®, or Parnate® in the past 14 days.

If you think you or someone else may have taken an overdose of this medicine, get emergency help immediately. Symptoms of an overdose include: extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin. In case of an overdose, call your doctor right away.

This medicine may be 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 instructions.

This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will increase 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 medicines for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while using this medicine.

Using narcotics for a long time can cause severe constipation. To help prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious problems.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal 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.

Dizziness, lightheadedness, or fainting may happen when you get up suddenly from lying down or sitting. Getting up slowly may help reduce this issue. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may cause adrenal insufficiency. Check with your doctor right away if you notice 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 stop using it suddenly without first talking to your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This may help lower the chance 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 that any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have discussed them 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 using 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

Inform your clinician if you have ever had any unusual or allergic reaction to this medication 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 hydrocodone, chlorpheniramine, and pseudoephedrine combination is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone, chlorpheniramine, and pseudoephedrine combination in the elderly. Nevertheless, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

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 before taking this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different drugs 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 essential that your healthcare professional know if you are taking any of the drugs listed below. 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 medicines is not advised. Your clinician may decide not to treat you with this medication or change some of the other drugs you take.

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

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

• Abametapir
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Dasabuvir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Midodrine
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Secretin Human
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Zavegepant
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications 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 drug with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

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

• Addison's disease (adrenal gland problem) or
• Alcohol abuse, history of or
• Brain tumor or
• Chronic obstructive pulmonary disease (COPD) or
• Diabetes or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (eg, BPH, prostatic hypertrophy) or
• Gallbladder disease or
• Head injury, history of or
• Increased pressure in the head or
• Pancreatitis, acute (swelling of the pancreas) or
• Seizures, history of or
• Thyroid disease—Use with caution. May raise chance for more severe adverse effects.

• Asthma, acute or serious or
• Heart disease (eg, coronary artery disease), serious or
• Hypertension (high blood pressure), serious or
• Narrow-angle glaucoma or
• Respiratory depression (extremely slow breathing) or
• Stomach or bowel issues (eg, paralytic ileus), known or suspected or
• Urinary retention (problems with passing urine)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

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

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

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

More common

• Fainting
• Lightheadedness
• Shakiness in the legs, arms, hands, or feet
• Trembling or shaking of the hands or feet
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

• Bloating
• Blurred vision
• Bulging soft spot on the head of an infant
• Change in the ability to see colors, especially blue or yellow
• Confusion
• Constipation
• Decrease in the frequency of urination
• Decrease in the urine volume
• Diarrhea
• Difficult or troubled breathing
• Difficulty in passing urine (dribbling)
• Dizziness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Drowsiness
• Fast, slow, or irregular heartbeat
• Headache
• Hives or welts, itching, skin rash
• Irregular, fast or slow, or shallow breathing
• Loss of appetite
• Loss of consciousness
• Nervousness
• Painful urination
• Pale or blue lips, fingernails, or skin
• Pounding in the ears
• Seizures
• Sore throat
• Spasm of the throat
• Stomach cramps or pain
• Sweating
• Tightness of the chest
• Vomiting
• 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

• Deep or fast breathing with dizziness
• Disturbed color perception
• Double vision
• Dry mouth
• False or unusual sense of well-being
• Fear or nervousness
• Halos around lights
• Nausea
• Night blindness
• Numbness of the feet, hands, and around the mouth
• Overbright appearance of lights
• Relaxed and calm feeling
• Restlessness
• Sleepiness or unusual drowsiness
• Trouble sleeping
• Tunnel vision

Incidence not known

• Belching
• Bigger, dilated, or enlarged pupils (black part of the eye)
• Bloating
• Change in color vision
• Chills
• Cold sweats
• Continuing ringing or buzzing or other unexplained noise in the ears
• Cool, pale skin
• Darkened urine
• Depression
• Difficulty seeing at night
• Feeling of constant movement of self or surroundings
• Fever
• Flushing or redness of the skin
• Full feeling
• Hearing loss
• Heartburn
• Increased appetite
• Increased hunger
• Increased in sexual ability, desire, drive, or performance
• Increased interest in sexual intercourse
• Increased sensitivity of the eyes to sunlight
• Increased sweating
• Indigestion
• Nightmares
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pressure in the stomach
• Sensation of spinning
• Slurred speech
• Stomach discomfort or upset
• Sugar in the urine
• Swelling of the abdominal or stomach area
• Swelling of the breasts or breast soreness in both females and males
• Unusually warm skin
• Watering of the eyes

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.

In the U.S.

• Hydron PSC
• Hyphed
• Notuss-Forte
• Zutripro

In Canada

• Vasofrinic Dh

Available Dosage Forms:

• Solution

Therapeutic Class: Antitussive, Opioid/Antihistamine/Decongestant Combination

Pharmacologic Class: Chlorpheniramine

Chemical Class: Hydrocodone

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.

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

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 (solution):For relief of cough, sneezing, or runny or stuffy nose: Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours. Children—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