Guaifenesin and Codeine

Each 5 ml (1 teaspoonful) contains:

Guaifenesin, USP: 100 mg

Codeine Phosphate, USP: 10 mg

(Warning: May be habit forming)

Alcohol 3.5 percent

In a palatable, aromatic syrup.

Inactive ingredients: Caramel, Citric Acid, FD&C Red 40, Flavors, Glycerin, Saccharin Sodium, Sodium Benzoate, Sorbitol, Water.

Last updated on RxList: 12/8/2004

Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

No information provided.

No information provided.

Last updated on RxList: 12/8/2004

No information provided.

Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone.

Directions

Take orally as stated below or use as directed by a doctor.

Adults and children 12 years of age and over: 2 teaspoonfuls every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period;

children 6 to under 12 years: 1 teaspoonful every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period;

children under 6 years: consult a doctor.

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.

Last updated on RxList: 12/8/2004

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

No information provided.

Last updated on RxList: 12/8/2004

No information provided.

No information provided.

Last updated on RxList: 12/8/2004

This syrup preparation combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough. As a result, dry, unproductive coughs become more productive and less frequent.

Last updated on RxList: 12/8/2004

See WARNINGS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

GUAIFENESIN/CODEINE - ORAL

(gweye-FEN-eh-sin/KO-deen)

COMMON BRAND NAME(S): Cheracol, Robitussin A-C

USES: This combination medication is used to temporarily treat coughing and chest congestion symptoms caused by the common cold, flu, or other breathing illnesses (e.g., sinusitis, bronchitis). Guaifenesin is an expectorant that helps thin and loosen mucus in the lungs, making it easier to cough up the mucus. Codeine is a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.

This medication is not usually used for ongoing coughs from smoking, asthma, other long-term breathing problems (e.g., emphysema), or for coughs with a lot of mucus, unless directed by your doctor.

This medication is not recommended for use in children younger than 2 years.

HOW TO USE: Take this medication by mouth with or without food, usually every 4 to 6 hours as needed with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication can be taken with food if stomach upset occurs. Drink plenty of fluids while you are using this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.

If you are using the liquid form, use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

This medication may cause dependence, especially if it has been used regularly for an extended time (more than a few weeks), or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

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

Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, facial flushing, nausea, vomiting, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: mental/mood changes (e.g., confusion, hallucinations), fast/irregular heartbeat, slow/shallow breathing, trouble urinating.

Seek immediate medical attention if this rare but very serious side effect occurs: seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), heart problems (e.g., irregular heartbeat), kidney disease, liver disease, mental/mood disorders (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.) To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to monitor/avoid these substances in your diet. Consult your doctor or pharmacist about using this medication safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness and drowsiness.

Caution is advised when using this drug in children because they may be more sensitive to the effects of this medicine, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell the doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: narcotic antagonists (e.g., naltrexone, naloxone).

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cimetidine, quinidine.

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

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (e.g., urine 5-HIAA levels, urine VMA levels), possibly causing false test results. 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.

OVERDOSE: 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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/slow/irregular heartbeat, slow/shallow breathing, cold/clammy skin, loss of consciousness.

NOTES: Do not share this product 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 that case.

MISSED DOSE: If you are prescribed this medication on a regular schedule and 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.

STORAGE: Store in a tightly closed container at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. 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 2008 Copyright(c) 2008 First DataBank, Inc.