Nighttime Cough Relief

Description

Dextromethorphan HBr, at a dosage of 30 mg, serves as a cough suppressant, while doxylamine succinate, present at 12.5 mg, functions as an antihistamine. The formulation contains 10% alcohol and is flavored with cherry.

Uses and Indications

This drug is indicated for the temporary relief of cold symptoms, including cough due to minor throat and bronchial irritation, as well as runny nose and sneezing.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 6 hours as needed. It is imperative that no more than 4 doses are taken within a 24-hour period.

The dosing cup provided with the product must be used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times to facilitate proper administration.

For children under 12 years of age, the product is not recommended for use. It is essential to adhere strictly to the dosing instructions provided.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Due to the potential for serious interactions, patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

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, use is contraindicated for a period of two weeks following the discontinuation of 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. Patients are advised to consult a doctor before using this product if they have any of the following conditions: glaucoma; a cough that produces excessive phlegm (mucus); a history of breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema; or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals taking sedatives or tranquilizers should seek guidance from a doctor or pharmacist before use.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients are also instructed to discontinue use and consult a doctor 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. Serious adverse reactions include the potential for excitability, particularly in children, and marked drowsiness. It is advised that patients avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the sedative effects.

In clinical practice, patients are instructed to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Patients should also seek medical advice prior to using this product if they have a history of glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider before use.

It is critical to note that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, as this may lead to serious interactions.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease.

Additionally, the use of alcohol, sedatives, and tranquilizers may potentiate drowsiness when taken with this medication. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking sedatives or tranquilizers. Monitoring for increased sedation and potential impairment is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cough Relief (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 product. In clinical observations, excitability may occur, particularly in children. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they experience difficulty urinating due to an enlarged prostate gland. This condition may be more prevalent in geriatric populations and could influence the safety and efficacy of the treatment.

Marked drowsiness is a potential side effect in elderly patients. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate this drowsiness, necessitating careful consideration of these substances during treatment.

Additionally, geriatric patients should exercise caution when driving a motor vehicle or operating machinery, as the risk of impaired alertness may be heightened. Monitoring for these effects is advised to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: excitability, particularly in children, and marked drowsiness. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with their doctor or pharmacist prior to using this product.

It is important for patients to stop using the product and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be experienced. 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.

Patients should be encouraged to consult a doctor before using this product if they have glaucoma, a cough that produces excessive phlegm (mucus), a breathing problem, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are currently taking sedatives or tranquilizers.

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 temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is not recommended for use in children under 12 years of age.

Clinicians should counsel patients to consult a doctor prior to use if they have conditions such as glaucoma, a cough with excessive phlegm, breathing problems, chronic cough associated with smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking sedatives or tranquilizers, and those who are pregnant or breastfeeding should consult a health professional before use.

Drug Information (PDF)

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

View product document (PDF)