GUAIFENESIN/HYDROCODONE - ORAL

GUAIFENESIN/HYDROCODONE - ORAL

PHONETIC PRONUNCIATION: (gwye-FEN-e-sin/HYE-droe-KOE-done)

COMMON BRAND NAME(S): Obredon

GENERIC NAME(S): guaifenesin/hydrocodone bitartrate

Uses

USES: This medication is used by adults to treat cough caused by the common cold. This product contains 2 medications: guaifenesin and hydrocodone. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways. Hydrocodone is a an opioid cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. This product is not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema, asthma) unless directed by your doctor. Do not use this product in children younger than 18 years. There is a risk of serious (rarely fatal) side effects, such as breathing problems. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms, such as drinking enough fluids, using a humidifier, or saline nose drops/spray.


How to use GUAIFENESIN/HYDROCODONE - ORAL

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking guaifenesin/hydrocodone and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food, as directed by your doctor, usually every 4 to 6 hours. Do not take more than 6 doses in a 24-hour period. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible). Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Drink plenty of fluids while you are taking this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs. Do not increase your dose or use this product more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Though it helps many people, this medication has a risk for abuse and may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your cough persists or worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, lightheadedness, nausea, vomiting, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating. Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, severe drowsiness/difficulty waking up. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking guaifenesin/hydrocodone, tell your doctor or pharmacist if you are allergic to it; or to other opioids (such as hydromorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), gall bladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate), cough with blood or large amounts of mucus. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. Hydrocodone passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydromorphone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Guaifenesin is available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing guaifenesin. Other medications can affect the removal of guaifenesin/hydrocodone from your body, which may affect how guaifenesin/hydrocodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This medication may interfere with certain laboratory tests (including amylase/lipase levels, urine levels of certain acids), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, coma.

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Faq for GUAIFENESIN/HYDROCODONE - ORAL

Guaifenesin/hydrocodone is a combination medication that contains guaifenesin, an expectorant, and hydrocodone, a narcotic cough suppressant.

Guaifenesin/hydrocodone is used to relieve cough and congestion associated with the common cold, flu, or other respiratory illnesses.

Guaifenesin works by thinning and loosening mucus in the airways, making it easier to cough up. Hydrocodone works by reducing the urge to cough.

Common side effects include drowsiness, dizziness, nausea, constipation, and dry mouth. Serious side effects may include slowed or shallow breathing, allergic reactions, and irregular heartbeat.

You should inform your doctor if you have any medical conditions such as asthma, liver or kidney disease, or a history of substance abuse. You should also let them know about any other medications you are currently taking.

It is not recommended to take guaifenesin/hydrocodone during pregnancy as it may harm the unborn baby. It may also pass into breast milk and harm a nursing baby. Consult your doctor before using this medication if you are pregnant or breastfeeding.

Follow the directions on your prescription label. Take the medication by mouth with or without food as directed. Do not exceed the recommended dosage or take it more often than prescribed.

Guaifenesin/hydrocodone may interact with other medications, including certain antidepressants, sedatives, muscle relaxants, and antihistamines. It is important to inform your doctor about all the medications you are taking.

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule.

The common side effects include dizziness, drowsiness, nausea, constipation, and stomach upset. It is important to consult a healthcare professional if these side effects become severe or persistent.

It is generally not recommended to consume alcohol while taking guaifenesin/hydrocodone as it may increase the risk of drowsiness, dizziness, and other side effects. It is best to consult a healthcare professional for personalized advice.

Hydrocodone, a component of guaifenesin/hydrocodone, is a narcotic medication that has the potential for addiction or dependence. It should only be used as prescribed and for the shortest duration possible.


Warning

WARNING: Taking guaifenesin/hydrocodone with other medications that may also cause drowsiness or breathing problems may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of guaifenesin/hydrocodone that works, and take it for the shortest possible time. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.