Childrens Robitussin Honey Nighttime Cough Dm

Description

Children's Robitussin Honey Nighttime Cough DM is a cough relief formulation designed for pediatric use. The product contains two active ingredients: Dextromethorphan HBr, which serves as a cough suppressant, and Diphenhydramine Succinate, an antihistamine. This formulation is alcohol-free and is characterized as long-acting, providing cough relief for up to 8 hours while also alleviating runny nose symptoms.

The product is flavored with True Source Certified Honey, enhancing its palatability. It is available in a volume of 4 fluid ounces (118 mL).

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 instruct patients to measure the dosage using only the dosing cup provided with the product, ensuring that the dosing cup remains with the product at all times.

For children under 6 years of age, the product is not recommended for use. For children aged 6 to under 12 years, the recommended dosage is 10 mL administered 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 not to exceed 4 doses in any 24-hour period.

It is essential to adhere to these dosing 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 uncertain whether a prescription drug contains an MAOI, consult a healthcare professional prior to use.

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

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 to avoid concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric disorders, or Parkinson's disease. This product should not be taken while on MAOIs or within two weeks of discontinuing such treatment. Healthcare professionals should advise patients to consult 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, individuals taking sedatives or tranquilizers should also consult a healthcare professional before using this product.

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

Patients are instructed to 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 product. 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 drowsiness, especially when combined with alcohol, sedatives, or tranquilizers, as these substances can exacerbate this effect. Patients are advised to avoid alcoholic drinks while using this product and to adhere strictly to the recommended dosage to minimize the risk of adverse effects.

Patients should 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.

Before using this product, patients should seek medical advice if they have conditions such as trouble urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues, including asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

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

Additionally, the use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. 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 concurrently 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 Childrens Robitussin Honey Nighttime Cough Dm (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 are advised to take 20 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Monitoring for this side effect is recommended during treatment.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

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 no specific data available regarding the excretion of this medication in 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 text 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 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.

No specific information is available regarding carcinogenicity, mutagenicity, or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: excitability, particularly noted in children.

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 help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in sedating children or inducing sleepiness. It is crucial to avoid using this medication if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking an MAOI drug 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 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 they should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for drowsiness. Additionally, patients should be informed that excitability may occur, particularly in children.

Patients should be encouraged 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 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 container requirements should be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any potential degradation of the product during storage and transportation.

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 Robitussin Honey Nighttime Cough Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)