Childrens Nighttime Mucus

Description

No description information is available for the 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. It is also effective in controlling cough to facilitate sleep. Additionally, this drug provides temporary relief from symptoms associated with hay fever or other upper respiratory allergies, including runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 chewable gels every 4 hours, with a maximum of 12 chewable gels within a 24-hour period. For children aged 6 to under 12 years, the dosage is 1 chewable gel every 4 hours, not to exceed 3 chewable gels in a 24-hour period.

Chewable gels should be chewed thoroughly before swallowing to ensure proper absorption.

Use is not recommended for children under 6 years of age. Dosage may be adjusted as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used to induce sleepiness in children. Additionally, it is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Furthermore, while using this product, it is essential to adhere to the recommended dosage and to avoid the consumption of alcoholic beverages. The combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, posing risks when driving or operating machinery.

Warnings and Precautions

The use of this product is contraindicated for the purpose of inducing sleep in children. It is imperative that this medication not be administered to 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, this product should not be used for a minimum 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 current prescription regimen.

General precautions should be observed prior to use, particularly in pediatric patients. Healthcare providers should be consulted if the child has any of the following conditions: a sodium-restricted diet, glaucoma, a cough accompanied by excessive phlegm, a history of respiratory issues such as asthma, chronic bronchitis, emphysema, or if there are difficulties with urination due to an enlarged prostate gland. Furthermore, individuals taking sedatives or tranquilizers should seek advice from a healthcare professional or pharmacist before using this product.

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 should be instructed to discontinue use and consult a physician if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions include marked drowsiness, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. Participants should be advised to avoid alcoholic drinks, as these substances can significantly increase drowsiness. Additionally, excitability may occur, particularly in children.

It is important for patients to be aware of specific warnings associated with this product. The 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 past two weeks should consult a healthcare professional before using this product.

Patients are advised to stop use and seek medical attention if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious condition. Furthermore, individuals with certain pre-existing conditions, such as a sodium-restricted diet, glaucoma, excessive phlegm production, chronic respiratory issues, or urinary difficulties due to an enlarged prostate gland, should consult a doctor prior to use.

In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Caution is also advised when driving or operating machinery due to the potential for drowsiness.

Drug Interactions

The use of this product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. Co-administration may result in serious interactions that could pose significant health risks.

Caution is advised when using this product in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness. Patients should be monitored for increased sedation and advised to exercise caution in activities that require full alertness, such as driving or operating heavy machinery.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 1 chewable gel every 4 hours, with a maximum of 6 chewable gels in a 24-hour period. In contrast, adults and children aged 12 years and older may take 2 chewable gels every 4 hours, not exceeding 12 chewable gels in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported 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 contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

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 on 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 individuals 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 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 as they arise.

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 develop during the course of treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness may occur, and excitability has been observed, particularly in children. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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. It is important to inform patients that this product should not be used to induce sleepiness in children.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery.

Providers should recommend that patients consult a doctor before using this product if the child has a sodium-restricted diet, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if there are difficulties urinating due to an enlarged prostate gland. Additionally, patients should be encouraged to speak with a doctor or pharmacist if they are currently taking sedatives or tranquilizers.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident safety seal. It is essential to inspect the seal prior to use; the product should not be utilized if the printed safety seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25ºC (68-77ºF). It is crucial to avoid refrigeration, as this may compromise the integrity of the product. Proper handling and adherence to these storage conditions are necessary to ensure the product's efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally and should be taken every 4 hours, or as directed by a healthcare provider. Clinicians should advise patients to consult a doctor before use if the patient has a sodium-restricted diet, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use. Pregnant or breastfeeding individuals are also encouraged to consult a healthcare professional before using the medication.

Drug Information (PDF)

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

View product document (PDF)