Robitussin Nighttime Cough Dm Soft Chews

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 is indicated for the temporary alleviation of symptoms related to 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 serves to control the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 chewable tablets every 6 hours as needed. It is important to ensure that the tablets are chewed completely before swallowing. The maximum allowable dosage is 4 doses, equivalent to 8 chewable tablets, within a 24-hour period, unless otherwise directed by a healthcare professional. This product is not intended for use in children under 12 years of age.

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 concomitant use of this product with MAOIs 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.

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 to induce 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 accompanied by excessive phlegm, or chronic respiratory issues such as those 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 interactions may occur.

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

Discontinuation and Consultation Patients are advised to discontinue use and consult a healthcare provider 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 using this product may experience a range of adverse reactions, which can vary in seriousness and frequency.

Marked drowsiness is a common reaction that may occur during the use of this product. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Additionally, excitability may occur, particularly in children.

Serious adverse reactions warrant immediate medical attention. 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.

Warnings are in place regarding the use of this product. It should not be used to sedate children or induce sleepiness in this population. Furthermore, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Patients uncertain about the presence of an MAOI in their prescription should seek guidance from a healthcare provider.

Patients with specific medical conditions should consult a doctor before using this product. These conditions include difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues such as those related to smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, patients are advised to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

The concomitant use of dextromethorphan and doxylamine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use these medications while on an MAOI or for a period of two weeks following the discontinuation of an MAOI due to the risk of severe interactions.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with dextromethorphan and doxylamine may potentiate drowsiness. It is advisable for healthcare providers to monitor patients for increased sedation and consider dosage adjustments as necessary to mitigate this effect.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Nighttime Cough Dm Soft Chews (dextromethorphan hydrobromide, 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. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in children under 12 years.

Geriatric Use

Elderly patients may experience increased sensitivity to the effects of this product, particularly regarding drowsiness. It is advised that geriatric patients exercise caution when using this product, especially if they have a history of conditions such as an enlarged prostate gland, glaucoma, or chronic respiratory issues, including asthma, chronic bronchitis, or emphysema.

Marked drowsiness may occur with the use of this product, and elderly patients should be advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may further enhance drowsiness. Care should be taken when driving or operating machinery due to the potential for impaired alertness.

This product is not intended for use in children under 12 years of age. Geriatric patients should consult with their healthcare provider prior to use to ensure safety and appropriateness of treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 patients 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 drug. 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 scenario.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions associated with the use of the product. These include drowsiness, excitability—particularly noted in children, and various allergic reactions such as rash, itching, and swelling. Additionally, gastrointestinal disturbances, including nausea and vomiting, have been reported. Confusion and hallucinations have been observed in elderly patients, along with urinary retention, dry mouth and throat, and blurred vision. It is important to note that these adverse reactions were reported during postmarketing surveillance and may not be included in the product's labeling.

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. Additionally, 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 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.

While using this product, patients should be made aware that marked drowsiness may occur. They should be 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. It is also important to inform patients 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 should seek advice from 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 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 in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)