Hydrocodone and pseudoephedrine (Oral)

Hydrocodone and pseudoephedrine combination is used in adults to relieve cough and nasal congestion (stuffy nose) caused by the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It works directly on the cough center in the brain to relieve cough. Pseudoephedrine is a decongestant, which reduces nasal congestion by narrowing the blood vessels and decreasing blood flow to the nasal passages.

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

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

It is very important for your doctor to check your progress while you are using this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it. If your cough does not improve or gets worse within 5 days, call your doctor.

It is illegal and dangerous for anyone else to use your medicine. Keep your unused oral liquid in a safe place.

Do not use this medicine if you are currently using or have used 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 medicine for allergies or colds, sedatives, tranquilizers, 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 using this medicine.

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

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

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

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

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

Make sure any doctor or dentist treating 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 medicine, the chances of taking the medication must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your physician 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 hydrocodone 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 and pseudoephedrine combination in the elderly. Nevertheless, elderly patients are more likely to have age-related kidney issues, which may require caution and an adjustment in the dose for patients receiving this medication.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential risks before using this drug while breastfeeding.

Interactions with Drugs

Although certain medications 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 using 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 drug with any of the following medications is not advised. Your clinician may decide not to treat you with this medicine or change some of the other medications you take.

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

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

• Abametapir
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• 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
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydromorphone
• 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
• 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
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• 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 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 as well 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 advised, 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
• 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 risk for more serious side 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 (very slow breathing) or
• Stomach or bowel issues (eg, paralytic ileus), known or suspected or
• Urinary retention (issues 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. Not all of these side effects may occur, but if they do, they may need medical attention.

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

More common

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• sweating
• unusual tiredness or weakness

Incidence not known

• Bloating
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• decrease in the frequency of urination
• decrease in urine volume
• diarrhea
• difficult or painful urination
• difficult or troubled breathing
• difficulty having a bowel movement
• difficulty in passing urine (dribbling)
• drowsiness
• frequent urge to urinate
• headache
• irregular, fast or slow, or shallow breathing
• loss of appetite
• nervousness
• pale or blue lips, fingernails, or skin
• pounding in the ears
• seizures
• shakiness in the legs, arms, hands, or feet
• stomach cramps or pain
• trembling or shaking of the hands or feet
• trouble with sleeping
• vomiting

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 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

• Fear
• mood changes
• nausea
• relaxed and calm feeling
• sleepiness
• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• Itching or skin rash
• weakness

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.

• Pancof HC
• Rezira

Pharmacologic Class: Pseudoephedrine

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 and nasal congestion: 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.

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