Robitussin Maximum Strength Nighttime Cough Dm

Description

No description information is available for the 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 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 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, 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. Concurrent consumption of alcoholic beverages is also discouraged, as alcohol, along with 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 an MAOI 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 smoking-related conditions, 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 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 using this product may experience marked drowsiness, which can be exacerbated by the consumption of alcoholic drinks, sedatives, or tranquilizers. It is advised that patients exercise caution when driving a motor vehicle or operating machinery due to the potential for increased drowsiness. Additionally, excitability may occur, particularly in children.

Patients should be aware of specific warnings regarding the use of this product. It is contraindicated for use in children for sedation purposes and should not be taken concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional prior to use.

Patients are advised to discontinue use and seek medical advice if a 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.

Before using this product, patients with certain medical conditions should consult a healthcare provider. These conditions include difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Furthermore, patients currently taking sedatives or tranquilizers should also seek guidance from a healthcare professional prior to use.

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

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 potentiate drowsiness, leading to enhanced sedation effects. 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 Robitussin Maximum Strength Nighttime Cough Dm (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. Children under this age should not be administered this medication. It is contraindicated to use this product for the purpose of sedation or to induce sleepiness in children. Additionally, healthcare professionals should be aware that excitability may occur, particularly in pediatric patients.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 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 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 inform patients that excitability may occur, particularly in children. Patients should be advised to stop using the medication 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 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 that produces 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, patients taking sedatives or tranquilizers should be advised to consult a doctor or pharmacist before using the medication.

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 should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours. The medication is not recommended for children under 12 years of age.

Clinicians are encouraged to educate patients about the potential for medicine abuse, particularly among teenagers, and can refer to resources such as www.StopMedicineAbuse.org for further information. No additional data are available regarding laboratory tests, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)