Tussin Cf Multi-Symptom Cold

Description

Tussin CF Multi-Symptom Cold is a liquid formulation designed for the relief of cough, mucus, and nasal congestion. The active ingredients include Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. This product is indicated for use in individuals aged 12 and over and is formulated to be non-drowsy.

The product is available in an 8 FL OZ (237 mL) volume and is distributed by Demoulas Supermarkets Inc., located at 875 East Street, Tewksbury, MA 01876. A seal warning is included, advising against use if the printed seal under the cap is torn or missing. It is important to note that this product is not manufactured or distributed by Pfizer, the owner of the trademark Robitussin®.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes. Additionally, it temporarily alleviates symptoms occurring with a cold, including nasal congestion and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 teaspoons every 4 hours as needed. It is important to note that no more than 6 doses should be administered within a 24-hour period. This product is not intended for use in children under 12 years of age.

Contraindications

There are no explicit contraindications identified for this product. However, it is advised that 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 prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication 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 discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. 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 be instructed to consult a healthcare provider. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is critical to obtain emergency medical assistance immediately or contact a Poison Control Center without delay. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if any of the following symptoms arise: nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, patients should seek medical advice. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical attention.

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

It is important to note that this medication should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment, as this may lead to serious interactions.

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 within two weeks of discontinuing 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, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Additionally, patients are advised to seek guidance from a healthcare professional before using this product if they are currently taking any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential pharmacodynamic interactions that may exacerbate side effects or diminish therapeutic efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Cf Multi-Symptom Cold (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. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated. Therefore, healthcare professionals should refrain from prescribing this product to children under this age limit.

Geriatric Use

Elderly patients may require careful consideration when using this adult strength product, which is not intended for use in children under 12 years of age. It is essential for healthcare providers to assess the appropriateness of this medication in geriatric patients, particularly those aged 65 and older, due to potential differences in pharmacokinetics and pharmacodynamics associated with aging.

Healthcare providers should monitor elderly patients closely for any adverse effects and consider the possibility of dose adjustments based on individual patient factors, including renal and hepatic function. Caution is advised when prescribing this medication to geriatric patients, as they may be more susceptible to side effects and may require tailored therapeutic approaches to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

Overdosage may lead to serious adverse effects that require prompt medical intervention. Healthcare professionals should be vigilant for symptoms indicative of overdosage, which may include severe dizziness, rapid heartbeat, and hallucinations.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Timely intervention is crucial to mitigate potential complications and ensure patient safety.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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, patients should seek medical advice. They should also be cautioned to stop use and consult a doctor if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

It is important for patients to consult with a doctor or pharmacist before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek professional guidance 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 reminded to consult a healthcare professional if they are taking any other oral nasal decongestant or stimulant.

Finally, patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

Storage and Handling

The product is supplied in a carton that contains essential information for use, which should be retained for reference. It is recommended to store the product at a temperature range of 20‐25 °C (68‐77 °F). Refrigeration is not advised, as the product should not be stored in cold conditions. Proper handling and storage are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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