Axiv Dm Max

Description

AXIV - DM MAX is a maximum strength cough relief formulation designed to provide effective cough suppression and expectoration. The product contains Dextromethorphan HBr as the active cough suppressant and Guaifenesin as the expectorant. It is presented in a liquid dosage form, with a total volume of 6 fluid ounces (177 mL). This formulation is non-drowsy, making it suitable for use during the day. The product is identified by the National Drug Code (NDC) 82706-024-01 and is comparable to Maximum Strength Mucinex® Fast-Max®.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may aid in promoting sleep.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. This product is specifically formulated for adult use and is not intended for children under 12 years of age.

Healthcare professionals should instruct patients to measure the dosage using the dosing cup provided with the product. It is essential to keep the dosing cup with the product to ensure accurate measurement and administration.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should consult a healthcare professional if uncertain whether their prescription includes an MAOI.

Additionally, exceeding the recommended dosage is contraindicated, as it may lead to adverse effects.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare professional before use.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a 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 may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). It is contraindicated to use this product concurrently with MAOIs or within two weeks of discontinuing such medications. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription contains an MAOI.

Common adverse reactions may include persistent or chronic cough, especially in patients with underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm should seek medical advice prior to use.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Axiv Dm Max (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This adult strength product is not intended for use in pediatric patients under 12 years of age. Children under 12 years should not use this medication.

Geriatric Use

Elderly patients may utilize this adult strength product; however, it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

It is crucial for healthcare providers to monitor elderly patients closely, as they may be more susceptible to adverse effects. Additionally, it is imperative that the recommended dosage is not exceeded to avoid potential complications. Caution should be exercised when prescribing this medication to geriatric patients, and appropriate dose adjustments should be considered based on individual patient needs and responses.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or adverse reactions.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

In summary, timely medical intervention and thorough monitoring are critical components in the management of overdose cases.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that patients should not exceed the recommended dosage of the medication.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns after improvement, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Additionally, healthcare providers should encourage patients to consult a doctor prior to using the medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

It is crucial to inform patients that they should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients who are uncertain whether their prescription includes an MAOI should be directed to consult their doctor or pharmacist before using this product.

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 temperature range of 15-30°C (59-86°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

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. It is contraindicated for use in children under 12 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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