Robitussin Honey Maximum Strength Nighttime Cough Dm

Description

Robitussin Honey Nighttime Cough DM is a maximum strength formulation designed for individuals aged 12 and older. It contains Dextromethorphan HBr, a cough suppressant, and Diphenhydramine Succinate, an antihistamine, which work synergistically to control cough and relieve symptoms such as runny nose and sneezing. The product is presented in a liquid dosage form, with a volume of 4 fluid ounces (118 ml). The formulation features a honey flavor profile, enhancing palatability. The product is identified by the carton code 62000000211557.

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 mL every 6 hours, with a maximum 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. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used to sedate children or induce sleepiness in pediatric patients. It is also contraindicated to exceed the recommended dosage. Concurrent consumption of alcoholic beverages is 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 to avoid concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric disorders, or Parkinson's disease. This contraindication extends to a period of two weeks following the cessation of MAOI therapy. 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, individuals currently taking sedatives or tranquilizers should also consult with a healthcare provider or pharmacist 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 should discontinue use and consult a physician 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 associated with the use of 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 concurrent use of alcohol, sedatives, or tranquilizers. Patients are advised to avoid alcoholic beverages while using this medication, as these substances may enhance drowsiness.

Patients should be instructed to stop 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 conditions such as difficulty 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, patients taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use. This medication should not be used to sedate children or to induce sleepiness in this population. It is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. If patients are uncertain whether their prescription includes an MAOI, they should seek clarification from a healthcare provider.

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 2 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 such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Honey Maximum Strength Nighttime Cough Dm (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. It is contraindicated for use in children under this age group, and healthcare professionals should not use it to sedate or induce sleepiness in children. Caution is advised, as excitability may occur, particularly in pediatric patients.

Geriatric Use

Elderly patients may require careful consideration when using this adult product, which is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any potential adverse effects. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and efficacy of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in 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 the safety of both the mother and the developing fetus.

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

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 there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

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 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement these measures swiftly to ensure optimal patient outcomes in cases of overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 assistance or contact a Poison Control Center immediately.

Patients should be informed that this medication is not intended for use in sedating children or inducing sleepiness. It is crucial to avoid using this product if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one within the past 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 must adhere strictly to the recommended dosage. They should be made aware that marked drowsiness may occur and are advised to 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 storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No additional information is available regarding laboratory tests, route, method, and frequency of administration, or postmarketing experience.

Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)