Nighttime Cough Dm

Description

DEXTROMETHORPHAN HBr is a cough suppressant indicated for the relief of cough. It is combined with DOXYLAMINE SUCCINATE, an antihistamine that aids in alleviating symptoms associated with allergies and colds. The formulation is presented in a liquid dosage form, flavored with menthol-berry, and is intended for use in individuals aged 12 years and over. Each bottle contains 4 fluid ounces (118 mL) of the product, and a dosage cup is included for accurate measurement. The packaging features tamper-evident seals; the product should not be used if the printed neck wrap is broken or missing, or if the imprinted safety seal under the cap is broken or missing.

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 associated with hay fever or other upper respiratory allergies, including itching of the nose or throat, sneezing, itchy and watery eyes, and runny nose. This drug 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 essential to utilize only the dosing cup included with the product to ensure accurate measurement.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General precautions should be observed before using this product. Patients are advised to consult a healthcare provider if they have a cough accompanied by excessive phlegm (mucus), glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing issues, including persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should seek advice from a doctor or pharmacist before use.

While using this product, patients should be aware that marked drowsiness may occur. The consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and therefore, it is recommended to avoid alcoholic beverages. Caution is advised when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Additionally, excitability may be observed, particularly in children.

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

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

Side Effects

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

Excitability has been reported, particularly in children, and patients should be aware of this possibility.

Patients are instructed to stop use and consult a doctor if their cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying 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. Additionally, patients taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

It is important to note that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or for two weeks following the discontinuation of such medications, as this may lead to serious adverse reactions.

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.

Additionally, caution is advised when this medication is used 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 types of medications.

The combination of alcohol, sedatives, and tranquilizers with this medication may potentiate drowsiness. Therefore, monitoring for increased sedation is recommended, and dosage adjustments may be necessary based on the clinical response and tolerance of the patient.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cough 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. 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 a Poison Control Center should be contacted.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment 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 general considerations associated with pharmacotherapy in 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 the safety of both the mother and the developing fetus.

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 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 not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 drug. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 and prepared to implement appropriate management strategies in response to an overdose scenario.

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 specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are drowsiness and excitability, particularly in pediatric populations.

Reports of overdose have been documented, with symptoms including severe drowsiness, confusion, agitation, hallucinations, nausea, vomiting, and respiratory depression.

Furthermore, safety updates from postmarketing data indicate an increased risk of drowsiness when the product is used in conjunction with alcohol, sedatives, or tranquilizers.

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 that the consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness and that they should avoid alcoholic beverages. Caution should be exercised when driving or operating machinery, as excitability may also 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 issues, including persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be encouraged to speak with their doctor or pharmacist if they are currently taking sedatives or tranquilizers before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

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, with a recommended dosage of 20 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use.

Additionally, information regarding the potential for medicine abuse, particularly among teenagers, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)