Tussin Cough Chest Congestion

Description

This formulation contains Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant, designed to relieve chest congestion and control cough while thinning and loosening mucus. It is classified as a maximum strength product and is suitable for adults and individuals aged 12 and over. The product is free from gluten and alcohol, ensuring compatibility for those with dietary restrictions. It is presented in a 4 FL OZ (118 mL) dosage form with a raspberry menthol flavor, providing a non-drowsy option for cough and chest congestion relief.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing cup provided with the product must be used for accurate measurement, and it should be kept with the product at all times. This formulation 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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 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 includes an MAOI.

Warnings and Precautions

Do not use this product in conjunction with any prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a current prescription, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough that is productive of excessive phlegm (mucus) or if they experience a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. 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 this product. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to use.

It is important for patients to seek medical advice before using this product if they experience a cough that is accompanied by excessive phlegm or if they have a chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

In the event of an overdose, patients are urged to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Cough Chest Congestion (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. The formulation is specifically designed for adults and is not intended for use in children within this age group. Caution is advised to ensure that pediatric patients do not receive this medication.

Geriatric Use

Elderly patients may use Tussin Cough Chest Congestion; however, the prescribing information does not provide specific recommendations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should consider the overall health status and comorbidities of geriatric patients when prescribing this medication, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the lack of targeted data for elderly patients.

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 currently no available data on 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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, patients should be cautioned against using this product for two weeks following the discontinuation of an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period and are advised to use the dosing cup provided, which should be kept with the product.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tussin Cough Chest Congestion, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)