Childrens Honeyworks Plus Nighttime Cough Syrup

Description

No description information is available.

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 runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. 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 ensure that the dosing cup provided with the product is used exclusively for measuring doses. The dosing cup should be kept with the product at all times to maintain accuracy in administration.

For children under 6 years of age, the product is contraindicated and should not be used. For children aged 6 to under 12 years, the recommended dosage is 10 ml every 6 hours, not to exceed 4 doses within a 24-hour period. For adults and children aged 12 years and older, the recommended dosage is 20 ml every 6 hours, also adhering to the maximum limit of 4 doses in any 24-hour period.

It is imperative to follow these guidelines to ensure safe and effective use of the product.

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.

This product should not be used to sedate children or induce sleepiness in pediatric patients. Additionally, it is contraindicated to exceed the recommended dosage. Consumption of alcoholic beverages is also discouraged, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness and increase the risk of adverse effects.

Warnings and Precautions

The use of this product is contraindicated for sedation in children; it should not be administered to induce sleepiness in pediatric patients. Additionally, it is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric disorders, or Parkinson's disease. The use of this product is also prohibited 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 current medications.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation 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 chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Furthermore, patients taking sedatives or tranquilizers should also consult with a healthcare professional before using this product.

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

Patients should discontinue use and consult a physician if their 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 may experience a range of adverse reactions while using this medication. Serious adverse reactions include marked drowsiness, which may significantly impair the ability to perform tasks that require alertness, such as driving a motor vehicle or operating machinery. Additionally, excitability has been reported, particularly in children, necessitating caution in this population.

Common adverse reactions may include drowsiness, which can be exacerbated by the consumption of alcoholic drinks, sedatives, or tranquilizers. Patients are advised to avoid these substances to minimize the risk of increased drowsiness.

Patients should discontinue use and consult a healthcare professional if their 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.

Before using this medication, patients should seek medical advice if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

This medication is contraindicated for use in children for the purpose of sedation or to induce sleep. It should also not be used in conjunction 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 dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This is due to the potential for serious interactions that may arise if dextromethorphan is administered while on an MAOI or within two weeks of discontinuing an MAOI.

In addition, caution is advised when using doxylamine succinate in conjunction with alcohol, sedatives, or tranquilizers. The combination of these substances may enhance drowsiness, necessitating careful monitoring of the patient's level of sedation and potential impairment. Adjustments to dosage or the timing of administration may be required to mitigate these effects.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Honeyworks Plus Nighttime Cough Syrup (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 10 ml every 6 hours. In contrast, adults and children 12 years and older should receive 20 ml every 6 hours.

Healthcare professionals should be aware that marked drowsiness may occur in pediatric patients, and excitability may be particularly pronounced 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 without delay.

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, or safety concerns pertinent to this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual patient factors may influence treatment outcomes. Monitoring for efficacy and safety is advised, given the lack of targeted data for this demographic.

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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 drug. 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 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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: excitability may occur, particularly in children. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur and that the consumption of alcoholic drinks should be avoided, as alcohol, sedatives, and tranquilizers can enhance drowsiness. It is important to inform patients to exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Healthcare providers should discuss the possibility of excitability, particularly in children, and advise patients to discontinue use and consult a doctor if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the medication if they have difficulty urinating due to an enlarged prostate gland, have glaucoma, or experience a cough associated with excessive phlegm (mucus). Additionally, patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Lastly, it is advisable for patients to consult a doctor or pharmacist 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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)