Tussiclear DH (Oral)

Guaifenesin and hydrocodone combination is used to help relieve cough and nasal congestion caused by 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 from 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 taking this medicine. This will help your doctor determine if the medicine is effective and if you should keep taking it. If your symptoms do not improve or worsen, call your doctor.

It is illegal and unsafe for anyone else to use your medicine. Store your unused oral liquid or tablets in a safe and secure location. People who are addicted to drugs may try to steal this medicine.

Do not use this medicine if you are currently using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the last 14 days.

This medicine may be habit-forming. If you notice that the medicine is not as effective, do not exceed your prescribed dose. Contact 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, difficulty or trouble breathing, irregular, fast, slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils, or yellowing of the eyes or skin.

This medicine may cause dizziness or drowsiness. Avoid driving or doing anything that could be dangerous until you know how this medicine affects you.

This medicine will enhance the effects of alcohol and other CNS depressants (medications that can cause drowsiness or reduce alertness). Some examples of CNS depressants include antihistamines or medications for allergies or colds, sedatives, tranquilizers, sleeping medications, other prescription pain medications or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these medications while using this medicine.

Using this medication can lead to severe constipation. To prevent this, your doctor may recommend laxatives, drinking plenty of fluids, or increasing fiber in your diet. Follow the instructions carefully, as ongoing constipation can cause more serious issues.

Dizziness, lightheadedness, or fainting may occur when you suddenly stand up from a lying or sitting position. Rising slowly may help reduce this issue. Lying down for a while may also help relieve dizziness or lightheadedness.

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

This medicine may cause adrenal insufficiency. Contact your doctor immediately if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, 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 suddenly without consulting your doctor. Your doctor may advise you to gradually decrease your dosage before stopping completely, which may help lessen the risk of withdrawal symptoms, such as stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Contact your doctor right away if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or hallucinations. These may indicate a serious condition called serotonin syndrome. Your risk may increase if you take certain other medications that affect serotonin levels in your body.

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

Do not take other medications unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medication, the chances of taking the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this drug, 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 issues, 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. Nevertheless, 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 medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medication while breastfeeding.

Interactions with Medications

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 physician may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially essential that your healthcare professional know if you are taking any of the medications 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 drugs is not recommended. Your physician may decide not to treat you with this medication or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

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

• 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 medications 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 is usually not advised, 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
• Grapefruit Juice

Other Medical Problems

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

• Acute pancreatitis (swelling of the pancreas) or
• Addison's disease (adrenal issue) 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 (serious 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 problems, history of or
• Stomach issues or
• Thyroid problems or
• Trouble urinating—Use with caution. May raise chance for more serious adverse effects.

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, 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

• 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. Your health care professional may also be able to tell you how 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

• 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