ROBITUSSIN A C
Summary: DRUG DESCRIPTIONGuaifenesin and CodeineEach 5 ml 1 teaspoonful contains Guaifenesin USP 100 mgCodeine Phosphate USP 10 mg Warning May be habit forming Alcohol 3 5 percentIn a palatable aromatic syrup Inactive ingredients Caramel Citric Acid FD Red 40 Flavors Glycerin Saccharin Sodium Sodium Benzoate Sorbitol Water INDICATIONSTemporarily 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 productiveDRUG INTERACTIONSCaution 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 WARNINGSA 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 CLINICAL PHARMACOLOGYThis 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 ConsumerIMPORTANT 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 pos 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 Therefor DRUG DESCRIPTIONGuaifenesin and CodeineEach 5 ml 1 teaspoonful contains Guaifenesin USP 100 mgCodeine Phosphate USP 10 mg Warning May be habit forming Alcohol 3 5 percentIn a palatable aromatic syrup Inactive ingredients Caramel Citric Acid FD Red 40 Flavors Glycerin Saccharin Sodium Sodium Benzoate Sorbitol Water INDICATIONSTemporarily 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 productiveDRUG INTERACTIONSCaution 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 WARNINGSA 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 CLINICAL PHARMACOLOGYThis 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 ConsumerIMPORTANT 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 pos 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 Therefor
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