Guaifenesin and hydrocodone (Oral)

Guaifenesin and hydrocodone combination is used to ease cough and nasal congestion that comes with the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It works directly on the cough center in the brain to reduce coughing. Guaifenesin helps clear mucus or phlegm from the chest when you have congestion due to a cold or flu. It does this by thinning the mucus or phlegm in the lungs.

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 will help your doctor see if the medicine is working properly and decide if you should keep taking it. If your symptoms do not improve or get worse, call your doctor.

It is illegal and dangerous for anyone else to use your medicine. Keep your unused oral liquid or tablets in a safe place. People who are addicted to drugs might try to steal this medicine.

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.

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 guidance.

If you think you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Signs of an overdose include dark urine, trouble breathing, irregular or fast or slow breathing, nausea or vomiting, upper stomach pain, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may make you feel dizzy or drowsy. Do not drive or do anything 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 pills, other prescription pain medicines 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 this medication can cause severe constipation. To prevent this, your doctor may recommend taking laxatives, drinking plenty of fluids, or increasing fiber in your diet. Be sure to follow the directions carefully, as ongoing constipation can lead to more serious issues.

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

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

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

If you have been using this medicine regularly for several weeks or longer, do not stop using it suddenly without first consulting your doctor. Your doctor may want you to slowly reduce the amount you are using before stopping it completely. This may help lessen the chance of withdrawal symptoms, such as abdominal cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Contact your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

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

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 chances of using the medicine must be weighed against the beneficial 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 medication or any other medications. 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

The use of hydrocodone in children younger than 6 years of age has caused severe breathing problems, sometimes causing death. Appropriate studies have not been performed on the relationship of age to the effects of guaifenesin and hydrocodone combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of guaifenesin and hydrocodone combination in the elderly. However, elderly patients are more likely to develop age-related kidney, liver, or heart 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 using this drug while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medications 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 drug, it is especially critical 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 medication with any of the following medications is not advised. Your clinician may decide not to treat you with this drug or change some of the other medications you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this drug with any of the following medications is typically not advised, 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 medications.

• 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
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• 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
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• 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
• 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 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 drug with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this drug, 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 clinician if you have any other medical issues, especially:

• Acute pancreatitis (swelling of the pancreas) or
• Addison's disease (adrenal problem) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing problems, serious (eg, hypoxia, hypercapnia) or
• Chronic obstructive pulmonary disease (COPD) or
• CNS depression or
• Cor pulmonale (severe heart condition) or
• Diabetes or
• Drug abuse or dependence, especially with narcotics, or history of or
• Enlarged prostate or
• Gallbladder disease or
• Head injuries or
• Increased pressure in the head or
• Mental health issues, history of or
• Stomach issues or
• Thyroid problems or
• Trouble urinating—Use with caution. May increase chance for more serious adverse effects.

• Asthma, acute or serious or
• Cough, chronic or persistent or
• Paralytic ileus (bowels stop working and may be blocked), known or suspected or
• Respiratory depression (extremely slow breathing)—Should not be used in patients with these conditions.

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

• Kidney disease, serious or
• Liver disease, severe—Use with caution. May make these conditions worse.

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

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

Incidence not known

• Agitation
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• changes in vision
• chills
• cough
• darkening of the skin
• diarrhea
• difficult, burning, or painful urination
• difficulty swallowing or breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position
• fainting
• fast heartbeat
• frequent urge to urinate
• hives, itching, skin rash
• irregular, fast or slow, or shallow breathing
• loss of appetite
• loss of consciousness
• mental depression
• nausea
• overactive reflexes
• pains in stomach, side, or abdomen, possibly radiating to the back
• pale or blue lips, fingernails, or skin
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• restlessness, shivering, talking, or acting with excitement you cannot control
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking, twitching
• unusual weight gain or loss
• 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, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• difficulty having a bowel movement
• feeling of warmth
• headache
• lack or loss of strength
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• stomach pain
• sudden sweating
• trouble sleeping

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.

• Canges-XP
• CodiClear DH
• ExeClear
• ExeCof XP
• Extendryl HC
• FluTuss XP
• Hydro-Tussin HG
• Monte-G HC
• Narcof
• Pancof XP
• Tussiclear DH
• Tusso-HC

Available Dosage Forms:

• Solution

Therapeutic Class: Antitussive, Opioid/Expectorant

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 relief of cough, sneezing, or runny or stuffy nose: For oral dosage form (solution): Adults—10 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 6 doses (60 mL) in 24 hours. Children—Use and dose must be determined by your doctor. For oral dosage form (tablets): Adults—1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours. Children—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.

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