Dg Health Tussin

Description

Maximum Strength Nighttime Cough DM is a combination formulation designed to provide relief from cough and associated symptoms. It contains Dextromethorphan HBr, a cough suppressant, and Doxylamine Succinate, an antihistamine. The product is available in a liquid dosage form, with a total volume of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with 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

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 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 induce sleep in children. It is also contraindicated to exceed the recommended dosage. 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 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 discontinued such medication within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI should be directed to consult with a healthcare provider or pharmacist prior to use.

Healthcare professionals should exercise caution and recommend that patients seek medical advice before 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, particularly those related to 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 indicate a serious underlying condition that requires further evaluation.

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 treatment. Patients are advised to avoid alcoholic beverages, as the combination of alcohol with this product can enhance drowsiness. Additionally, the use of sedatives or tranquilizers may further increase this effect. Participants should exercise caution when driving or operating machinery due to the potential for drowsiness.

Excitability has been reported, particularly in children, and may be a notable reaction during the use of this product.

Serious adverse reactions may arise in specific populations. Patients with certain pre-existing conditions, such as trouble urinating due to an enlarged prostate gland, glaucoma, or chronic respiratory issues (including emphysema or chronic bronchitis), should consult a healthcare professional before using this product. Furthermore, individuals experiencing a persistent or chronic cough, especially those associated with smoking, asthma, or emphysema, should seek medical advice prior to use.

Patients are also cautioned against using this product in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, as this could lead to serious interactions.

If a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should discontinue use and consult a healthcare provider, as these symptoms may indicate a serious underlying condition.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. 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 initiating therapy if they are currently taking these agents.

The co-administration of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Therefore, monitoring for increased sedation is recommended in patients who are using these substances concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Tussin (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, 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 marked drowsiness may occur with use, and excitability has been reported, particularly in children. Caution is advised when considering this product for pediatric patients.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 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 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 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 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 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 healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness may occur with the use of this product. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for drowsiness. Additionally, excitability may be observed, particularly in children.

No specific information is available regarding carcinogenicity, mutagenicity, or detailed animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate instances of marked drowsiness and excitability, particularly in pediatric populations. Additionally, there have been observations of increased drowsiness when the product is used concurrently with alcohol, sedatives, or tranquilizers. These events were reported voluntarily or through surveillance programs and are included for informational purposes.

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. Additionally, patients should 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. It is essential to encourage patients 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 accompanied by excessive phlegm (mucus), or any breathing problems such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also be advised to seek medical guidance prior to use.

Finally, patients should be encouraged to speak 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 should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Clinicians should counsel patients on the potential for marked drowsiness, advising them to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery. Additionally, excitability may occur, particularly in children. It is important for patients to use 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 Dg Health Tussin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)