Honeyworks Plus Adult Nighttime Cough Syrup

Description

No description information is available for the specified 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. 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

The dosing of this product should be measured exclusively with the dosing cup provided, which must be kept with the product at all times. For adults and children aged 12 years and older, the recommended dosage is 20 milliliters (ml) every 6 hours, with a maximum limit of 4 doses within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it is contraindicated for this population.

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; consult a healthcare professional if uncertain about the presence of an MAOI in prescribed medications.

• The product should not be used to sedate children or induce sleepiness in pediatric patients.

• Administration should not exceed the recommended dosage.

• Concurrent use with alcoholic beverages is contraindicated, as alcohol may enhance drowsiness and sedation effects.

Warnings and Precautions

The use of this product is associated with specific warnings and precautions that healthcare professionals must consider to ensure patient safety.

Warnings This product is contraindicated for use in children for the purpose of sedation or inducing sleepiness. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is imperative to consult a healthcare provider or pharmacist prior to use.

General Precautions Healthcare professionals should advise patients to seek medical consultation 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 (mucus).

• Chronic respiratory issues, including a cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients should be cautioned to consult a doctor or pharmacist if they are concurrently taking sedatives or tranquilizers, as these may interact with the product.

Emergency Medical Help Instructions In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center without delay.

Stop Taking and Call Your Doctor Instructions Patients should be instructed to discontinue use and consult a healthcare provider 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.

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, which may necessitate careful monitoring.

Common adverse reactions may include increased drowsiness, especially when the medication is taken in conjunction with alcohol, sedatives, or tranquilizers, as these substances can exacerbate this effect. Patients are advised to avoid alcoholic drinks while using this medication to mitigate the risk of enhanced sedation.

Patients should be instructed to stop use and consult a doctor if their cough persists for more than 7 days, returns, 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, patients taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI, as this may result in serious interactions.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this product may enhance drowsiness. It is advisable for patients to exercise caution and consider dosage adjustments or increased monitoring of sedation levels when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Honeyworks Plus Adult Nighttime Cough Syrup (dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. Caution is advised as excitability may occur, particularly in children. Additionally, this product should not be used to sedate a child or to induce sleepiness.

Geriatric Use

Elderly patients may experience increased sensitivity to this adult product, which is not intended for use in children under 12 years of age. It is essential for geriatric patients to consult a healthcare provider prior to use, particularly if they have conditions such as difficulty urinating due to an enlarged prostate gland, glaucoma, or respiratory issues including chronic cough, asthma, chronic bronchitis, or emphysema.

Additionally, elderly patients should seek advice from a doctor or pharmacist if they are currently taking sedatives or tranquilizers, as the concomitant use of these medications may heighten the risk of marked drowsiness. Given the potential for drowsiness, it is advised that geriatric patients avoid alcoholic beverages, as alcohol can exacerbate this effect. Caution is also recommended when driving or operating machinery due to the risk of impaired alertness.

It is important to note that excitability may occur, particularly in younger populations, but geriatric patients should remain vigilant regarding their overall response to the medication. Monitoring for adverse effects and adjusting dosages as necessary may be warranted in this population to ensure safety and efficacy.

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.

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 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 situation, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness and excitability, particularly in children, may occur as non-teratogenic effects. There is no additional information available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included drowsiness and excitability, particularly noted in children. Allergic reactions such as rash, itching, and swelling have also been documented. Additionally, gastrointestinal disturbances, including nausea and vomiting, were reported. Some patients experienced confusion and hallucinations, while urinary retention, dry mouth, and throat, as well as blurred vision, were also noted. These reactions were reported during the use of the product in the postmarketing setting.

Patient Counseling

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

Patients must be informed that this medication should not be used to sedate a child or induce sleepiness. Additionally, it is crucial to avoid using this product if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription includes an MAOI, they should consult with a doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and consult a doctor 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 condition.

When using this product, patients should adhere strictly to the recommended dosage. They should be made aware that marked drowsiness may occur and that the consumption of alcoholic beverages should be avoided, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for drowsiness. Patients should also be informed that excitability may occur, particularly in children.

Healthcare providers should encourage patients to consult a doctor before using this medication 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, patients taking sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned 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, 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 of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)