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

Adults and children 12 years and older are advised to take 10 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing must be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure accurate measurement.

This product is not intended for use in children under 12 years of age.

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. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI before 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, the 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.

Healthcare professionals should exercise caution and recommend that patients consult a doctor 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 advised to seek guidance from a doctor or pharmacist if they are concurrently taking any other oral nasal decongestants or stimulants.

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

Patients should discontinue use and contact their 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, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious reactions warrant immediate medical attention, particularly if patients 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 underlying condition that requires evaluation by a healthcare professional.

Common adverse reactions may include those related to pre-existing health conditions. Patients with heart disease, diabetes, high blood pressure, thyroid disease, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should consult a doctor before using this product. Furthermore, individuals experiencing a cough that produces excessive phlegm or those with urinary difficulties due to an enlarged prostate gland should also seek medical advice prior to use.

It is crucial for patients to refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such medication within the past two weeks. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare provider or pharmacist for clarification.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination can result in serious interactions that may pose significant health risks. It is essential for healthcare providers to ensure that patients are not concurrently using MAOIs before initiating treatment with this medication.

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 within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

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

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to monitor these 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient following an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that patients must not exceed the recommended dosage.

Healthcare providers should encourage patients to consult with their doctor prior to use if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), a cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

Additionally, patients should be instructed to speak with their doctor or pharmacist before using this medication if they are currently taking any other oral nasal decongestants or stimulants. This will help ensure safe and effective use of the medication.

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 the product's 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 who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the medication 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)