Tussin Cf

Description

This formulation contains Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. It is alcohol-free and designed for adult use in individuals aged 12 years and older. The product is indicated for the relief of cough, nasal congestion, chest congestion, and mucus. The packaging includes a tamper-evident safety seal, and the product should not be used if this seal is broken or missing.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions, specifically for the temporary alleviation of nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief in the context of colds and is not a cure for underlying respiratory infections. It should be used as directed and is not recommended for prolonged use without medical supervision.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 10 mL administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

Healthcare professionals should instruct patients to measure the dosage exclusively with the dosing cup provided with the product. The dosing cup should be kept with the product to ensure accurate measurement and administration.

This product is not intended for use in children under 12 years of age. Therefore, it is essential to advise against its use in this population.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use. Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), a cough that produces excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be cautioned to consult a doctor or pharmacist before using this product if they are concurrently taking any other oral nasal decongestants or stimulants.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical attention should be sought. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious condition requiring medical attention.

Before initiating treatment, patients with pre-existing conditions such as heart disease, diabetes, high blood pressure, or thyroid disease should seek medical advice. Furthermore, individuals with a chronic cough, particularly those related to smoking, asthma, chronic bronchitis, or emphysema, as well as those experiencing cough with excessive phlegm, should also consult a healthcare provider. Patients who have difficulty urinating due to an enlarged prostate gland should seek guidance prior to use.

It is also recommended that patients consult a doctor or pharmacist before using this product if they are currently taking any other oral nasal decongestants or stimulants, as interactions may occur.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a current prescription, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare provider before using this product in conjunction with any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential adverse interactions and to ensure safe and effective use of the product.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Cf (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this product have not been established in children younger than 12. Therefore, it is contraindicated for use in this age group.

Geriatric Use

Elderly patients may require special consideration when using this product, as it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL every 4 hours.

It is essential for healthcare providers to advise geriatric patients to consult a physician prior to use if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, chronic cough (especially if related to smoking), asthma, chronic bronchitis, emphysema, or if they experience a cough accompanied by excessive phlegm (mucus). Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product.

Monitoring for potential adverse effects and ensuring appropriate dosage adjustments may be necessary to enhance safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-122. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved and the individual patient's response. Monitoring for any adverse effects is essential, and supportive care should be initiated as necessary.

Management of an overdose may include symptomatic treatment and supportive measures tailored to the specific clinical scenario. It is vital to assess the patient's condition thoroughly and provide appropriate interventions based on the severity of the symptoms presented.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. It is important to inform patients that they should also stop use and consult a doctor if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they experience difficulty urinating due to an enlarged prostate gland. Lastly, it is essential to recommend that patients consult a doctor or pharmacist before using this product if they are taking any other oral nasal decongestants or stimulants.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Tussin Cf, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)