Tussin Cf

Description

No description information is available for the 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 2 teaspoons every 4 hours. It is important to note that no more than 6 doses should be taken within a 24-hour period. This product is specifically formulated for adult strength and is not intended for use in children under 12 years of age.

For children under 12 years, the same dosage of 2 teaspoons every 4 hours applies; however, healthcare professionals should exercise caution and consider the appropriateness of this dosage based on the child's age and weight.

Contraindications

There are no explicit contraindications associated with the use of this product. However, it is advised that the product should not be used in excess of the directed dosage. Adhering to the recommended usage is essential to ensure safety and efficacy.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised that this product not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, 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, patients should contact their healthcare provider. These symptoms may indicate a more serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Currently, there are no specific laboratory tests recommended for the safe use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks.

Patients are advised to stop use and consult a healthcare professional if they experience symptoms such as 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, these may indicate a serious condition requiring medical attention.

Before using this medication, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. 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, should also consult a healthcare provider prior to use.

Patients taking any other oral nasal decongestants or stimulants should discuss their current medications with a doctor or pharmacist 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 Cf (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This adult strength product is not intended for use in pediatric patients under 12 years of age. For patients aged 12 years and older, the recommended dosage is 2 teaspoons every 4 hours. In children under 12 years, the same dosage of 2 teaspoons every 4 hours is indicated; however, caution is advised due to the product's formulation being designed for adult use.

Geriatric Use

Elderly patients may require special consideration when using this product, which is not intended for use in children under 12 years of age. Prior to use, it is advisable for geriatric patients to consult a healthcare provider, particularly if they have pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

It is crucial for elderly patients to adhere strictly to the recommended dosage and not exceed the directed amount. Monitoring for adverse effects is important; patients should discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, it is essential to consult a healthcare provider. Persistent cough lasting more than 7 days, or a cough that recurs or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition that requires medical evaluation.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions, including anaphylaxis, have been documented. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Cardiovascular events, including hypertension and arrhythmias, have been observed. Additionally, central nervous system effects, including hallucinations and seizures, have been noted. Gastrointestinal disturbances, such as nausea and vomiting, have been included in the reported experiences.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience symptoms such as 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, they should seek medical attention, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage when using this product. Before initiating use, patients should be encouraged to consult a doctor if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking any other oral nasal decongestants or stimulants to avoid potential interactions.

Storage and Handling

The product is supplied in a carton that contains a dosage cup for accurate measurement. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. Healthcare professionals are advised to retain the carton to access the full Directions for Use, ensuring proper handling and administration.

Additional Clinical Information

No further data are available.

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)