Tussin Dm Nighttime Max

Description

No description information is available for the specified drug.

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, and it is imperative not to exceed the recommended dosage. Consumption of alcoholic beverages is contraindicated, 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 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, particularly those related to smoking, asthma, or emphysema, should also consult a physician. It is advisable for patients to discuss their use of sedatives or tranquilizers with their healthcare provider or pharmacist before initiating treatment with this product.

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 be categorized by seriousness and frequency.

Serious adverse reactions include marked drowsiness, which may occur during use. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Additionally, excitability has been reported, particularly in children. 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.

Common adverse reactions may include drowsiness, which necessitates caution when driving or operating machinery. Patients should be aware that the product should not be used to induce sleep in children and is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication.

Patients with specific medical conditions should consult a healthcare professional before use. These conditions include trouble urinating due to an enlarged prostate gland, glaucoma, cough associated with excessive phlegm, and chronic respiratory issues such as emphysema or chronic bronchitis. Furthermore, individuals taking sedatives or tranquilizers should also seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare provider 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.

Drug Interactions

The concomitant use of Tussin DM Nighttime Max with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use Tussin DM Nighttime Max while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI, as this combination may result in serious interactions.

Additionally, the use of Tussin DM Nighttime Max in conjunction with alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients are advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery, during this combination. Monitoring for increased sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Dm Nighttime Max (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 individuals under 12 years.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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. 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 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

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 to address any complications that may develop during the course of treatment.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the product. Reports from voluntary submissions and surveillance programs indicate the following events:

Drowsiness and excitability, particularly in pediatric patients, have been noted. Allergic reactions, including rash, itching, and swelling, were also reported. Gastrointestinal disturbances such as nausea and vomiting were observed in some individuals. Additionally, confusion and hallucinations were documented in a subset of patients. Other reported events include urinary retention, increased heart rate (tachycardia), and dry mouth and throat.

These reactions were identified during the postmarketing surveillance of the product.

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 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. 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 advised to consult with a 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 any degradation of the product.

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 use in children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial 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.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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