A-COF DH Oral

This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., bronchitis, sinusitis, common cold). This product is generally not used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema), unless directed by your doctor. This product contains two medicines, guaifenesin and hydrocodone. Guaifenesin is called an expectorant. It works by making phlegm in the breathing tubes more fluid. This helps the cough to clear phlegm better. Hydrocodone is a narcotic cough suppressant that works by decreasing the feeling of needing to cough.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the 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).

Take this medication by mouth with or without food, usually every 4-6 hours or as directed by your doctor. For best results, take with a full glass of water. The dosage is based on your age, medical condition, and response to treatment. If you are using the liquid form, measure the dose carefully using a special medication spoon or oral measuring syringe. Do not use a household spoon. Do not take more than the maximum daily dose for your age group unless instructed to do so by your doctor.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

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 runny nose, sweating, restlessness, widened pupils, loss of appetite, goose bumps, irritability, shakiness, . fast heartbeat and muscle/bone pain) 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 immediately.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently or use it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your cough persists or worsens after more than 1 week or if you also have fever, headache, or rash.

Nausea, vomiting, constipation, dizziness, sleepiness, loss of appetite, nervousness, dry mouth, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., 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 immediately if any of these unlikely but serious side effects occur: difficulty staying awake, confusion, slow/shallow breathing, difficult/painful urination, irregular heartbeat, mental/mood changes (e.g., depression, hallucinations).

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking guaifenesin/hydrocodone, tell your doctor or pharmacist if you are allergic to it; or to sulfites; or to other narcotics (e.g., codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., severe chronic obstructive pulmonary disease-COPD, advanced emphysema), increased pressure in the brain (intracranial hypertension), certain bowel diseases (e.g., paralytic ileus), intoxication with medications which cause sleepiness or slow/shallow breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (e.g., due to enlarged prostate, urethral stricture), personal or family history of regular use/abuse of drugs/alcohol, breathing problems (e.g., asthma, mild chronic obstructive pulmonary disease-COPD, moderate/severe sleep apnea), smoking, cough with large amounts of phlegm, kidney disease, liver disease, heart disease, low blood pressure, gallbladder/biliary tract problems, swollen pancreas (pancreatitis), certain brain problems (e.g., brain tumor, lesions), head injury, seizures, slow/irregular heartbeat, adrenal gland problems (e.g., Addison's disease), mental/mood disorders (e.g., toxic psychosis), a certain spine problem (kyphoscoliosis), recent surgery, underactive thyroid (hypothyroidism), a severe loss of body water (dehydration), severe obesity, stomach pain of unknown cause.

This drug may cause dizziness, drowsiness, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing, drowsiness, dizziness).

Caution is advised when using this drug in children because they may be more sensitive to its side effects (e.g., slow/shallow breathing, drowsiness, dizziness).

This medication should be used only when clearly needed during pregnancy. It is not recommended for use over long periods or in high doses near the expected delivery date because it may harm the unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: buprenorphine, butorphanol, nalbuphine, pentazocine, naltrexone.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, or after treatment with this medication. In some rare cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amphetamines (e.g., methylphenidate, mixed amphetamine salts), water pills (diuretics such as furosemide), drugs affecting liver enzymes that remove hydrocodone from your system (e.g., cimetidine, rifamycins including rifampin).

Tell your doctor or pharmacist if you also take drugs that may cause drowsiness, slow your breathing, or lower your blood pressure such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives, hypnotics), muscle relaxants, other narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, tricyclics such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

Guaifenesin is available in both prescription and nonprescription products. Check the labels of all your medications carefully to make sure you are not taking more than one product containing guaifenesin.

This product can affect the results of certain lab tests (e.g., uric acid levels, 5-hydroxyindoleacetic acid levels, vanillylmandelic acid levels). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: vomiting, slow/shallow breathing, slow heartbeat, inability to wake up, weakness, cold/clammy skin.

Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.

Drink plenty of fluids while taking this medication unless your doctor instructs you otherwise. This may help to relieve congestion.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.