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 menthol-berry to enhance palatability. Each package includes a dosage cup for accurate measurement. This product is intended for use by individuals aged 12 years and older. The actual bottle size is 4 fluid ounces (118 mL), as indicated on the side panel.

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 provides temporary relief from symptoms related to hay fever or other upper respiratory allergies, including itching of the nose or throat, itchy and watery eyes, runny nose, and sneezing. This medication also aids in controlling the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed the directed amount, and patients must not take more than four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 6 hours as needed. It is imperative that only the dosing cup included with the product is utilized for accurate measurement.

Children under 12 years of age should not use this medication.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used 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 they are uncertain whether their prescription medication contains an MAOI.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they experience a cough accompanied by excessive phlegm (mucus), have a history of glaucoma, encounter difficulties in urination due to prostate gland enlargement, or suffer from respiratory issues such as persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, it is essential to consult a doctor or pharmacist if the patient is concurrently taking sedatives or tranquilizers.

While using this product, patients may experience marked drowsiness. It is recommended to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution should be exercised when driving or operating machinery due to the potential for impaired alertness. Additionally, excitability may occur, particularly in pediatric patients.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients using this product may experience marked drowsiness, which can be exacerbated by the consumption of alcoholic drinks, sedatives, or tranquilizers. It is advised that patients exercise caution when driving a motor vehicle or operating machinery due to the potential for increased drowsiness. Additionally, excitability may occur, particularly in children.

Patients should be aware of the serious warning against the concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. This product should not be used while taking an MAOI or for two weeks following the discontinuation of an MAOI.

Patients are advised to stop use and consult a doctor if their cough persists for more than seven days, tends to recur, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have a cough associated with excessive phlegm, glaucoma, difficulty urinating due to prostate enlargement, or any breathing problems, including persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking an MAOI or within two weeks of discontinuing an MAOI. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking sedatives or tranquilizers to ensure safe and effective use.

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 medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL, administered every 6 hours using the dosing cup provided.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when prescribing this medication to pediatric patients.

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 potential 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 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 prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly in accordance with established medical protocols.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness and excitability, particularly in children, may occur as non-teratogenic effects. There is no specific information available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, no specific data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include drowsiness, excitability—particularly noted in children—various allergic reactions such as rash, itching, and swelling, as well as gastrointestinal disturbances including nausea and vomiting. Additionally, confusion and hallucinations have been reported in some patients, along with urinary retention, dry mouth and throat, and blurred vision.

Further safety updates from postmarketing experience indicate reports of misuse and abuse, especially among adolescents and young adults. There is also an increased risk of respiratory depression when this product is used in conjunction with other central nervous system depressants.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients 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. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, 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 should be made aware that marked drowsiness may occur. They should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for drowsiness. Additionally, patients should be informed that excitability may occur, particularly in children.

Patients should be encouraged to consult a doctor before using this product if they have a cough associated with excessive phlegm (mucus), glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems, including persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking sedatives or tranquilizers should be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 20 mL every 6 hours for adults and children aged 12 years and older. 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, immediate medical assistance or contact with a Poison Control Center is necessary.

Additionally, clinicians may refer to resources such as www.StopMedicineAbuse.org to educate about the potential for medicine abuse among teenagers. No further information is available regarding laboratory tests or postmarketing experiences.

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.

View product document (PDF)