Sda Laboratories Tussin Dm

Description

TussinDM is a pharmaceutical formulation indicated for the relief of cough and associated symptoms. It contains dextromethorphan as its active ingredient, which acts as a cough suppressant. The product is available in a liquid dosage form, characterized by its syrupy consistency. TussinDM is typically presented in a clear to slightly hazy solution, with a color that may range from colorless to light amber. The formulation is designed for oral administration, providing a convenient method for patients to manage cough symptoms effectively.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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 teaspoonfuls (10 mL) every 4 hours as needed, or as directed by a healthcare professional. It is imperative that patients do not exceed 6 doses within a 24-hour period and adhere strictly to the recommended dosage to avoid potential adverse effects.

For children under 12 years of age, the use of this medication is not advised. Healthcare professionals should ensure that patients are informed of these guidelines to promote safe and effective use of the medication.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

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, this 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 use.

Individuals with a known allergy to any of the ingredients in this product should refrain from its use to avoid potential allergic reactions.

Before using this product, it is advisable for patients to consult a healthcare provider if they are experiencing a cough accompanied by excessive phlegm (mucus) or if they have a chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a prolonged headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals with specific contraindications. The use of this product is not recommended for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication, as this may lead to significant interactions. Additionally, individuals with a known allergy to any of the ingredients in this product should avoid its use.

Common adverse reactions may include a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or headache. In such cases, it is advised that patients stop using the product and consult a healthcare professional, as these symptoms could indicate a more serious underlying condition.

Patients are also encouraged to seek medical advice prior to using this product if they have a cough accompanied by excessive phlegm or if they have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require 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, psychiatric or emotional conditions, and 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 verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls (10 mL). It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 regarding 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

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 from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up care.

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. It is important to emphasize the potential risks associated with overdose. Patients should be instructed to seek medical help or contact a Poison Control Center immediately in the event of an overdose. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should take the medication every 4 hours as needed or as directed by a healthcare professional, ensuring not to exceed 6 doses within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)