Guaifenesin and hydrocodone (oral route)

Brand Name

US Brand Name

Canges-XP

CodiClear DH

ExeClear

ExeCof XP

Extendryl HC

FluTuss XP

Hydro-Tussin HG

Monte-G HC

Narcof

Pancof XP

Tussiclear DH

Tusso-HC

Description

Guaifenesin and hydrocodone combination is used to treat cough and to loosen mucus associated with the common cold.

Hydrocodone is an opioid antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Guaifenesin is used to help clear mucus or phlegm from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

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

This product is available in the following dosage forms:

Solution

Before Using

In deciding to use a medicine, the risks of taking 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

Tell your doctor 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

The use of hydrocodone in children younger than 6 years of age has caused serious 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 problems 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.

Breastfeeding

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

Drug Interactions

Although certain medicines 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 doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone
Safinamide
Samidorphan

Using this medicine with any of the following medicines is usually not recommended, 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 medicines.

Abametapir
Acepromazine
Aclidinium
Alfentanil
Almotriptan
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Apalutamide
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asenapine
Atazanavir
Atropine
Avacopan
Baclofen
Belladonna
Belzutifan
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzphetamine
Benzthiazide
Benztropine
Berotralstat
Biperiden
Boceprevir

Other Interactions

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 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 medicine with any of the following is usually not recommended, 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

Proper Use

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 with a 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 treatment of cough and to loosen mucus:
- 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 opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid 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

Precautions

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If your symptoms do not improve or if they get worse, call your doctor.

If your cough does not improve or if it gets worse within 5 days, call your doctor.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused oral liquid or tablets in a safe and secure place.

Using this medicine could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

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

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

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and nalmefene to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

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 add to 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, or sleeping medicine, other prescription pain medicine or opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

Using this medication can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may 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 right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

This medicine may cause adrenal gland problems. 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.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Check with 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 symptoms 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 (unable to have children). Talk with your doctor before using this medicine 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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
chest tightness
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
tingling of the hands or feet
trembling or shaking twitching
unusual weight gain or loss
vomiting
yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bloody or cloudy urine
change in consciousness
chest pain or discomfort
cold and clammy skin
coughing that sometimes produces a pink frothy sputum
decreased awareness or responsiveness
difficulty or trouble breathing
extreme drowsiness
general feeling of discomfort or illness
increased sweating
irregular, fast or slow, or shallow breathing
irregular heartbeat
lightheadedness, dizziness, or fainting
loss of consciousness
no blood pressure or pulse
no muscle tone or movement
not breathing
pale or blue lips, fingernails, or skin
severe sleepiness
slow or irregular heartbeat
stopping of heart
sudden decrease in the amount of urine
swelling in the legs and ankles
unpleasant breath odor

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

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.

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