Tussin Cf

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

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, as the use of any other dosing device may lead to inaccurate dosing. The dosing cup should be kept with the product to ensure proper measurement.

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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated while using this product.

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, this product should not be used for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General precautions should be observed. Patients should seek medical advice 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, it is important to consult a doctor or pharmacist before use if the patient is taking any other oral nasal decongestant or stimulant. Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

Patients are instructed to discontinue use and contact 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 accompanied by fever, rash, or a persistent headache, medical advice should be sought, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should 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, medical advice should be sought. A cough that persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI, as this may result in serious interactions.

Additionally, caution is advised when considering the use of this medication in conjunction with other oral nasal decongestants or stimulants. The potential for additive effects exists, and it is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to combining these agents.

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 medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may utilize this adult product; however, it is not intended for use in children under 12 years of age. For adult patients, including those aged 65 and older, the recommended dosage is 10 mL every 4 hours.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to monitor elderly patients closely for any adverse effects or changes in therapeutic response, and to consider potential dose adjustments based on individual patient factors.

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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 established 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. Therefore, a thorough assessment of the patient's condition is essential. Management of an overdose typically involves supportive care and may require specific interventions based on the clinical presentation.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate treatment protocols as guided by the severity of the symptoms and the specific circumstances of the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions associated with the use of the product. These include nervousness, dizziness, sleeplessness, rash, and persistent headache. Such reactions have been reported voluntarily or identified through surveillance programs and may occur in patients using the product.

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.

Patients should be informed 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. Additionally, it should not be used for 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 prior to using this product.

Patients must be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop use and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. Furthermore, patients should be cautioned to stop use and contact 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.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product 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 guidance if they have a cough that produces excessive phlegm or if they experience difficulty urinating due to an enlarged prostate gland.

Lastly, patients should be instructed to consult a doctor or pharmacist before using this product if they are currently 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 and storage conditions must be adhered to in order to maintain product efficacy and safety.

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 before using the medication. Additionally, it is crucial to keep the product out of reach of children, and 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)