Tussin Dmmax

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 aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 mL of the medication using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period to avoid potential overdose.

For accurate dosing, the medication must be measured exclusively with the dosing cup included in the packaging; the use of this cup with other products is not recommended.

This medication is not indicated for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage. Adhering to the recommended usage is essential to ensure safety and efficacy.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product must not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be taken for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription medications.

General Precautions This product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Stop Taking and Call Your Doctor 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 symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Get Emergency Medical Help In cases of overdose, it is crucial to seek emergency medical assistance or contact the Poison Control Center immediately.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant interactions.

Common adverse reactions include the need to stop use and consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, patients are advised to seek medical advice before using this medication if they experience a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate a different therapeutic approach.

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 an MAOI. The combination can result in serious interactions that may pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not necessary in the absence of other interacting agents.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose. In cases where an overdose is suspected, immediate assessment of the patient's condition is critical.

Healthcare providers should monitor for any unusual symptoms that may arise, as these can vary widely depending on the substance involved. Common signs of overdose may include altered mental status, respiratory distress, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose should be initiated promptly. This includes ensuring the patient's airway is clear, providing supplemental oxygen if necessary, and establishing intravenous access for fluid resuscitation or medication administration. Activated charcoal may be considered if the patient presents within a suitable timeframe and is alert enough to protect their airway.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult with a medical toxicologist for guidance on specific treatment protocols and antidotes, if applicable. Continuous monitoring and supportive care are paramount until the patient stabilizes or further medical intervention is warranted.

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 identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, itching, and swelling.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

It is important to emphasize that patients should not exceed the recommended dosage when using this product. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a cough associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is also important to advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)