Cough Dm

Description

No description information is available for the specified drug.

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 and administration guidelines.

For adults and children aged 12 years and older, the recommended dose is 20 mL administered every 6 hours as needed. It is imperative that patients do not exceed 4 doses within a 24-hour period.

Patients should utilize only the dose cup provided with the medication to ensure accurate dosing.

The medication is not recommended 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) or within 2 weeks of discontinuing such medication, due to the potential for serious interactions. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription.

Consumption of alcoholic beverages is contraindicated, as alcohol may exacerbate drowsiness. Additionally, the use of sedatives and tranquilizers in conjunction with this product may further increase drowsiness, necessitating caution when driving or operating machinery.

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 discontinuation 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.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they have a cough accompanied by excessive phlegm (mucus), glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing issues such as emphysema or chronic bronchitis. Furthermore, individuals with a persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, should also consult a healthcare provider. It is essential for patients to inform their doctor or pharmacist if they are concurrently taking sedatives or tranquilizers.

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

Patients are instructed to discontinue use and consult a healthcare professional if their cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients using this product may experience a range of adverse reactions. Marked drowsiness is a common side effect, and patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate this drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

In certain cases, excitability may occur, particularly in children. Patients should be instructed to stop use and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Warnings indicate that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, which are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Patients with specific medical conditions should seek medical advice prior to use. This includes those experiencing a cough with excessive phlegm, individuals with glaucoma, those facing difficulties in urination due to prostate enlargement, and patients with respiratory issues such as emphysema or chronic bronchitis. Additionally, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist before using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children 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 pediatric patients. It is essential 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 efficacy, 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Patients with renal impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data may impact treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness may occur with the use of this product, and the concomitant use of alcohol, sedatives, or tranquilizers may enhance this effect. Additionally, excitability has been observed, particularly in pediatric populations.

No further information is available regarding nonclinical toxicology or 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 elderly patients, alongside urinary retention and dry mouth and throat.

Further safety updates from postmarketing experience indicate reports of misuse and abuse of dextromethorphan, especially among adolescents and young adults. There is also an increased risk of respiratory depression when dextromethorphan 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 one week, recurs, or is accompanied by symptoms such as fever, rash, or 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 a motor vehicle or operating machinery. Additionally, patients should be informed that excitability may occur, particularly in children.

Healthcare providers should recommend that patients 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 such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking sedatives or tranquilizers should be encouraged to discuss their medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. 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 inventory management and product safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before use. Additionally, 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.

For information on the potential for medicine abuse among teens, resources are available at www.StopMedicineAbuse.org. No further details are provided regarding laboratory tests or postmarketing experience.

Drug Information (PDF)

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

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