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|Guaifenesin/Hydrocodone Sustained-Release Tablets

Guaifenesin/Hydrocodone Sustained-Release Tablets

Guaifenesin/Hydrocodone Sustained-Release Tablets is used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin/Hydrocodone Sustained-Release Tablets is a cough suppressant and expectorant combination. It works by loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Guaifenesin/Hydrocodone Sustained-Release Tablets if:

• you are allergic to any ingredient in Guaifenesin/Hydrocodone Sustained-Release Tablets or any other codeine or morphine-related medicine (eg, oxycodone)
• you are taking sodium oxybate (GHB)
• you have increased pressure in the brain, trouble breathing, or diarrhea due to antibiotic use

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin/Hydrocodone Sustained-Release Tablets:

Some medical conditions may interact with Guaifenesin/Hydrocodone Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an underactive thyroid
• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus
• if you have recently had any head injury, brain injury or tumor, infection of the brain or nervous system, epilepsy, or seizures
• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Guaifenesin/Hydrocodone Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine because it may increase the risk of Guaifenesin/Hydrocodone Sustained-Release Tablets"s side effects
• Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of severe drowsiness or breathing problems may be increased
• Naltrexone because it may decrease Guaifenesin/Hydrocodone Sustained-Release Tablets"s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Hydrocodone Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin/Hydrocodone Sustained-Release Tablets:

Use Guaifenesin/Hydrocodone Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Guaifenesin/Hydrocodone Sustained-Release Tablets by mouth with or without food.
• Swallow Guaifenesin/Hydrocodone Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Drink plenty of water while taking Guaifenesin/Hydrocodone Sustained-Release Tablets.
• If you miss a dose of Guaifenesin/Hydrocodone Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Hydrocodone Sustained-Release Tablets.

Important safety information:

• Guaifenesin/Hydrocodone Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Hydrocodone Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not bet better within 5 to 7 days or if they get worse, check with your doctor.
• Guaifenesin/Hydrocodone Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Guaifenesin/Hydrocodone Sustained-Release Tablets.
• Tell your doctor or dentist that you take Guaifenesin/Hydrocodone Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Guaifenesin/Hydrocodone Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Guaifenesin/Hydrocodone Sustained-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Hydrocodone Sustained-Release Tablets while you are pregnant. It is not known if Guaifenesin/Hydrocodone Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Guaifenesin/Hydrocodone Sustained-Release Tablets.

Possible side effects of Guaifenesin/Hydrocodone Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; change in amount of urine; difficulty urinating; hearing change or loss; mental or mood changes; severe drowsiness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Store Guaifenesin/Hydrocodone Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Hydrocodone Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Guaifenesin/Hydrocodone Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Guaifenesin/Hydrocodone Sustained-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Guaifenesin/Hydrocodone Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.