Tussin Multi Symptom Cold 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.

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 is not advised. 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 contraindicated for 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. Due to the potential for serious interactions, patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

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, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough that is productive with excessive phlegm. Furthermore, individuals with a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider. It is important to inform the doctor or pharmacist if the patient is taking any other oral nasal decongestants or stimulants. Patients must adhere to the recommended dosage and should not exceed the directed amount.

Patients are advised 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 associated with fever, rash, or a persistent headache, medical attention should be sought, as these may indicate a serious condition.

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

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur. 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 further evaluation.

Common adverse reactions may include those related to pre-existing health conditions. Patients with heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before using this medication. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema, are advised to consult a healthcare provider prior to use.

Patients currently taking any other oral nasal decongestants or stimulants should also seek guidance from a doctor or pharmacist before using this medication to avoid potential interactions.

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, as this may result in serious interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Multi Symptom Cold 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, defined as those aged 65 years and older, should exercise caution when using this product. It is important to note that this formulation is not intended for use in children under 12 years of age. For adult patients, including those aged 12 years and older, the recommended dosage is 10 mL every 4 hours.

Before initiating treatment, geriatric patients should consult with a healthcare provider if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or difficulties with urination due to an enlarged prostate gland. These conditions may necessitate careful monitoring and potential dose adjustments to ensure 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 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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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

No postmarketing experience details are available in the insert.

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 be instructed to refrain from 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 informed to discontinue use and consult a doctor 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 develop a fever. It is important to instruct patients to stop use and contact a doctor if their cough persists for more than seven days, returns, 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 using this product if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, 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. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is also important to advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)