Good Sense Tussin Dm

Description

GoodSense® Tussin DM is a non-drowsy formulation designed for the relief of cough and chest congestion in adults and individuals aged 12 and over. This product contains Dextromethorphan HBr as a cough suppressant and Guaifenesin as an expectorant, effectively alleviating symptoms associated with cough and mucus buildup. The formulation is presented in a raspberry flavor and is packaged in a 4 FL OZ (118 mL) dosage, with a dosage cup included for accurate measurement. GoodSense® Tussin DM is comparable to the active ingredients found in Robitussin® Cough + Chest Congestion DM.

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.

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 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 should be measured exclusively with the dosing cup provided with the product, which 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 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

Do not use this product in conjunction with any prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is contraindicated for use within two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription medications.

General precautions should be taken prior to use. Patients are advised to seek medical consultation if they experience a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and contact their healthcare provider if a 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 patient should contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is crucial to note that the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment, as this may lead to serious interactions.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Additionally, patients should seek medical advice prior to using this medication if they have a cough associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate a different therapeutic approach.

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 Good Sense Tussin Dm (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this product, as it is not intended for this age group. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in a 24-hour period. It is important to keep this product out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 effectively. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Postmarketing experience has identified several adverse reactions associated with the use of this product. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additional reported events include hallucinations, confusion, agitation, increased heart rate, respiratory depression, seizures, and hepatotoxicity. Other serious adverse events have been documented; however, their frequency remains unknown.

The safety of this product has not been established in pregnant or breastfeeding women. There have also been reports of misuse and abuse of dextromethorphan. Cases of overdose have been observed, with symptoms such as confusion, dizziness, and respiratory depression noted in these instances. Furthermore, the potential for serotonin syndrome has been recognized in patients concurrently taking dextromethorphan with other serotonergic medications. It is important to note that adverse reactions may occur more frequently in patients with underlying health conditions or those on multiple medications.

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 at least two weeks after discontinuing 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 more serious underlying condition.

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

Storage and Handling

The product is supplied in a configuration that includes 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. Proper storage conditions must be maintained to ensure 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 Good Sense Tussin Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)