Tussin Nighttime Cough

Description

This product is a maximum strength nighttime cough suppressant formulated for adults and individuals aged 12 and over. It contains Dextromethorphan HBr as the active ingredient, which effectively relieves cough, itchy throat, and runny nose. The formulation also includes Doxylamine Succinate, an antihistamine that aids in alleviating symptoms associated with colds and allergies.

The product is presented in a 4 fluid ounce (118 mL) dosage form and features a berry menthol flavor. It is free from gluten and alcohol, ensuring suitability for individuals with specific dietary restrictions.

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

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. It is important to note that this product is not intended for use in children under 12 years of age. Therefore, individuals under this age should not use 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 induce sleep in children. Additionally, it is contraindicated to exceed the recommended dosage. 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 in certain situations. It should not be used to induce sleepiness in children. Additionally, it is prohibited for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Healthcare professionals should be consulted before using this product in patients with specific medical conditions. These include difficulty urinating due to an enlarged prostate gland, glaucoma, cough associated with excessive phlegm, or any breathing issues such as emphysema or chronic bronchitis. Furthermore, individuals with a persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, should seek medical advice prior to use.

Patients currently taking sedatives or tranquilizers should also consult a doctor or pharmacist before using this product, as interactions may occur.

During the use of this product, it is imperative to adhere strictly to the recommended dosage. Users should be aware that marked drowsiness may occur, and the consumption of alcoholic beverages is discouraged. The combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery, as excitability may be observed, particularly in children.

If a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, it is essential to discontinue use and seek medical advice. A persistent cough may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended (1-800-222-1222).

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 to induce sleep 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. Furthermore, individuals with certain medical conditions, such as trouble urinating due to an enlarged prostate gland, glaucoma, or chronic respiratory issues like emphysema or chronic bronchitis, should consult a doctor before using this product.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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 disorders, or Parkinson's disease.

Additionally, caution is advised when this medication is used 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.

The combination of this medication with alcohol, sedatives, or tranquilizers may potentiate drowsiness. Therefore, monitoring for increased sedation is recommended, and dosage adjustments may be necessary based on the clinical response and tolerance of the patient.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Nighttime Cough (dextromethorphan hydrobromide, 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, as it is not intended for this age group. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when considering the use of this product in pediatric populations.

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 the specific needs and health status of geriatric patients when prescribing. Monitoring for adverse effects and assessing the need for dosage adjustments may be necessary to ensure safety and efficacy in this population.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 currently no available data on the excretion of this drug 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 studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs and clinical status.

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

Marked drowsiness has been reported in postmarketing experience. The concomitant use of alcohol, sedatives, and tranquilizers may enhance this drowsiness. Additionally, excitability has been observed, particularly in pediatric populations.

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 inform patients that this product should not be used to induce sleepiness in children.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional 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 underlying condition.

When using this product, patients must adhere to the recommended dosage and be 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. Additionally, patients should be informed that excitability may occur, particularly in children.

Healthcare providers should recommend that patients consult a doctor before using this product if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough that produces excessive phlegm, or a breathing problem such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking sedatives or tranquilizers should be encouraged to consult with a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

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 humidity.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients may experience marked drowsiness; therefore, it is advised to avoid alcoholic beverages. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating caution when driving or operating machinery. Clinicians should also be aware that excitability may occur, particularly in children.

Drug Information (PDF)

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

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