Tussin Dm

Description

DEXTROMETHORPHAN HBr is a cough suppressant indicated for the relief of cough. DOXYLAMINE SUCCINATE serves as an antihistamine, providing additional symptomatic relief. The formulation is flavored with raspberry, blackberry, and menthol to enhance palatability. It is intended for use by individuals aged 12 years and older. A dosage cup is included to ensure accurate administration. The product is labeled with a maximum strength claim based on the maximum daily dose of the active ingredients. The actual bottle size is 4 FL OZ (118 mL), as indicated on the side panel.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a cold. Additionally, it is indicated for the temporary relief of symptoms associated with hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat.

This drug also serves to control the impulse to cough, thereby facilitating sleep.

Dosage and Administration

The dosing of this product should be measured exclusively with the dosing cup provided, which must be kept with the product at all times. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. 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 the following situations:

• It should not be used to induce sleep in children.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, and extends for 2 weeks after discontinuation of the MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, caution is advised when using this product, including adherence to recommended dosages and avoidance of alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should exercise caution when driving or operating machinery.

Patients should discontinue use and consult a healthcare professional 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 underlying condition.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

It is imperative to adhere to the following general precautions when administering this medication. This product should not be used to induce sleepiness in children. Additionally, it is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. The use of this product is also prohibited for a period of 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 prescription medications.

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

No specific laboratory tests are recommended for monitoring the use of this medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. A persistent cough may indicate a serious underlying condition, warranting immediate medical attention. Patients are advised to discontinue use and consult a healthcare professional if the cough lasts for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Before initiating treatment, patients should seek medical advice if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough that produces excessive phlegm (mucus), or any breathing problems, including emphysema or chronic bronchitis. Additionally, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a healthcare provider prior to use.

Patients currently taking sedatives or tranquilizers are also advised to speak with a doctor or pharmacist before using this medication to avoid potential interactions.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are currently taking a prescription MAOI or within two weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease.

Caution is advised when considering the use of this medication in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these classes of medications.

Additionally, the co-administration of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Therefore, patients should be monitored for increased sedation and advised to avoid activities that require full alertness until they are aware of how these substances affect them.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Dm (dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is not intended for this age group. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when considering the use of this product in pediatric populations.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as with any medication prescribed to elderly individuals.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring of vital signs and laboratory parameters may be necessary to assess the patient's condition and guide further treatment decisions.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 the product. Marked drowsiness has been reported, which may be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers. Additionally, excitability has been noted, particularly in pediatric populations.

It is important to recognize that a persistent cough may indicate a serious underlying condition. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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 important to inform patients that this product should not be used to induce sleepiness in children.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and consult a healthcare professional 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.

When using this product, patients must adhere strictly to the recommended dosage. They should be made aware that marked drowsiness may occur and are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery. Additionally, patients should be informed that excitability may occur, particularly in children.

Patients should be encouraged to consult a healthcare provider before using this product if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough that produces excessive phlegm, or any breathing issues such as emphysema or chronic bronchitis. They should also seek advice if they have a persistent or chronic cough associated with smoking, asthma, or emphysema.

Lastly, patients taking sedatives or tranquilizers should be advised to consult their doctor or pharmacist before using this product.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding.

Patients should be advised to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Notably, the medication may cause marked drowsiness; therefore, patients are cautioned to avoid alcoholic beverages and be aware that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is also recommended when driving or operating machinery, as excitability may occur, particularly in children. Patients should measure the dosage using the provided dosing cup and ensure it is kept with the product.

Drug Information (PDF)

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

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