Careone Tussin Dm

Description

CAREone® TUSSIN DM NIGHTTIME COUGH is a maximum strength formulation designed for the relief of cough, itchy throat, and runny nose. This product contains the active ingredients dextromethorphan HBr, a cough suppressant, and doxylamine succinate, an antihistamine. It is intended for use by adults and individuals aged 12 and over. The product is gluten-free and is available in a 4 FL OZ (118 mL) dosage form, featuring a raspberry, blackberry, and menthol flavor. This formulation is comparable to the active ingredients found in Robitussin® Maximum Strength Nighttime Cough DM, providing effective nighttime relief as compared to the previous 10 mL formula.

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 relief of 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 serves to control the impulse to cough, thereby facilitating sleep.

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 for consistent use.

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. It is important to note that this product is not intended for use in children under 12 years of age. Therefore, healthcare providers should advise against administering this product to individuals in this age group.

Contraindications

Use is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to the risk of serious interactions.

The product should not be used to induce sleepiness in children. Additionally, it is contraindicated to exceed the recommended dosage. Consumption of alcoholic beverages is also contraindicated, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Warnings and Precautions

The use of this product is contraindicated for the purpose of inducing sleep in children. It is imperative that healthcare professionals advise patients against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Patients should be encouraged to consult with a healthcare provider or pharmacist if they are uncertain whether their prescription includes an MAOI.

Healthcare professionals should exercise caution and recommend that patients seek medical advice prior to using this product 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 respiratory issues such as emphysema or chronic bronchitis. Additionally, patients with a persistent or chronic cough, which may be indicative of smoking, asthma, or emphysema, should also consult a physician. It is advisable for patients taking sedatives or tranquilizers to discuss their medication regimen with a healthcare provider or pharmacist before use.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. A persistent cough may signal a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions include marked drowsiness, which may occur during use. 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 risk of impaired alertness.

Common adverse reactions may include excitability, particularly in children. Patients should be vigilant for signs of serious conditions, such as a cough that lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. In such cases, it is essential to discontinue use and consult a healthcare professional.

Patients with specific medical conditions should seek medical advice before using this product. These conditions include trouble urinating due to an enlarged prostate gland, glaucoma, cough associated with excessive phlegm, and breathing problems such as emphysema or chronic bronchitis. Additionally, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor prior to use.

This product is contraindicated for use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Patients uncertain about their prescription medications should consult a healthcare provider or pharmacist for clarification. It is also advisable for patients taking sedatives or tranquilizers to seek medical advice before using this product.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication if they are currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

Caution is advised when considering the use of this medication in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, the co-administration of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Therefore, patients should be monitored for increased sedation and advised to avoid activities that require full alertness until they are aware of how these substances affect them.

Packaging & NDC

Below are the non-prescription pack sizes of Careone Tussin Dm (dextromethorphan hbr, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 6 hours.

Healthcare professionals should be aware that marked drowsiness may occur, necessitating caution when driving a motor vehicle or operating machinery. Additionally, excitability may be observed, particularly in children. This product is specifically not intended for use in pediatric patients under 12 years.

Geriatric Use

Elderly patients may experience marked drowsiness when using this product. It is advised that these patients avoid alcoholic beverages, as the consumption of alcohol, sedatives, and tranquilizers can further enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness and coordination.

This product is not intended for use in children under 12 years of age, and healthcare providers should consider these factors when prescribing to geriatric patients. Monitoring for increased sedation and advising on safety precautions is essential to ensure the well-being of elderly patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 prescribing information 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 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 marked drowsiness occurring with the use of this product. Additionally, there have been reports of excitability, particularly in children, associated with its use. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to instruct patients not to exceed the recommended dosage.

Patients should be made aware that marked drowsiness may occur while using this medication. They should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Providers should emphasize the need for caution when driving or operating machinery due to the potential for drowsiness.

Healthcare providers should inform patients that excitability may occur, particularly in children. It is essential to recommend that patients 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 accompanied by excessive phlegm (mucus), or any breathing problems such as emphysema or chronic bronchitis. Additionally, patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Finally, patients should be encouraged to consult with their doctor or pharmacist if they are currently taking sedatives or tranquilizers to ensure safe use of 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 exposure to extreme temperatures or environmental factors that may compromise the product's quality.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians should counsel patients about the potential for marked drowsiness, advising them to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery due to the risk of drowsiness and possible excitability, particularly in children. Patients should be instructed to use only the dosing cup provided with the product and to keep it with the medication for accurate measurement.

Drug Information (PDF)

This file contains official product information for Careone Tussin Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)