Nighttime Cough

Description

Dextromethorphan HBr is a cough suppressant utilized in the formulation. Doxylamine succinate serves as an antihistamine component. The product is flavored with raspberry, blackberry, and menthol to enhance palatability. It is presented in a liquid dosage form, with a total volume of 4 fluid ounces (118 mL).

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. It is also 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. Additionally, this drug controls the impulse to cough, thereby aiding in sleep.

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for medical advice or treatment of underlying conditions.

Dosage and Administration

Healthcare professionals should instruct patients to measure the dosage using only the dosing cup provided with the product, ensuring that the dosing cup remains with the product for consistent use.

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. It is important to note that this product is not intended for use in children under 12 years of age. Therefore, healthcare providers should advise against administering this product to individuals in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used to induce sleep in children. It is also contraindicated to exceed the recommended dosage. Consumption of alcoholic beverages is discouraged, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness and increase the risk of adverse effects.

Warnings and Precautions

Patients should not use this product to induce sleepiness in children. It is contraindicated for individuals 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 following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Healthcare professionals should advise patients to seek medical guidance prior to using this product if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or any breathing issues such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, should also consult a physician. Furthermore, it is important to inquire about the concurrent use of sedatives or tranquilizers before administration.

While using this product, patients must adhere strictly to the recommended dosage. Marked drowsiness may occur, and patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the potential for impaired alertness. Additionally, excitability may be observed, particularly in pediatric patients.

Patients should discontinue use and consult a healthcare provider if a 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 a range of adverse reactions, which can vary in seriousness and frequency.

Marked drowsiness is a common side effect that may occur during treatment. Patients are advised to avoid alcoholic beverages, as the combination of alcohol with this product can enhance drowsiness. Additionally, the use of sedatives or tranquilizers may further increase this effect, necessitating caution when driving or operating machinery.

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

Warnings indicate that this product should not be used to induce sleepiness in children or in conjunction with prescription monoamine oxidase inhibitors (MAOIs). Patients currently taking an MAOI or who have stopped taking one within the last two weeks should consult a healthcare professional before using this product.

Patients with specific medical conditions, such as trouble urinating due to an enlarged prostate gland, glaucoma, or chronic respiratory issues (including emphysema or chronic bronchitis), should seek medical advice prior to use. Furthermore, individuals experiencing a persistent or chronic cough, particularly those associated with smoking or asthma, should also consult a healthcare provider.

Patients are advised to discontinue use and seek medical attention if their cough lasts longer than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for conditions such as depression, psychiatric disorders, or Parkinson's disease.

Caution is advised when considering the use of this medication in conjunction with sedatives or tranquilizers. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy 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 understand how these substances affect them.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cough (dextromethorphan hydrobromide, 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 dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 general considerations 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

Patients with renal impairment have not been specifically addressed in the drug insert 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 an overdose. Symptoms 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 children.

No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no detailed data provided on animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to refrain from using it to induce sleepiness in children. It is crucial to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. Patients who are uncertain whether their prescription contains an MAOI should be encouraged to consult with their doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and seek medical advice 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 be cautioned to adhere strictly to the recommended dosage. They should be made aware that marked drowsiness may occur and that they should avoid consuming alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should also be advised to exercise caution when driving or operating machinery due to the potential for drowsiness. Additionally, healthcare providers should inform patients that excitability may occur, particularly in children.

Patients should be encouraged to consult with their 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 problems 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. Furthermore, patients taking sedatives or tranquilizers should be advised to consult with 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 should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

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 on several important considerations: individuals who are pregnant or breastfeeding should consult a healthcare professional prior to use. Patients should be advised to keep the medication out of reach of children and to be aware that marked drowsiness may occur, necessitating the avoidance of alcoholic beverages. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving or operating machinery, and excitability may be observed, 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 Nighttime Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)