Maximum Strength Cough Plus Chest Congestion Dm

Description

VALUMEDS™ is a maximum strength formulation designed to relieve cough and mucus associated with chest congestion. Each liquid-filled capsule contains Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant. This product is comparable to the active ingredients found in Robitussin® Maximum Strength Cough + Chest Congestion DM. The packaging includes 10 softgels, providing a convenient dosage form for effective symptom relief.

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

The maximum recommended dosage for adults and children aged 12 years and older is 2 softgels every 4 hours, not to exceed 12 softgels within a 24-hour period. This product is specifically formulated for adult use and is not intended for children under 12 years of age. It is imperative that healthcare professionals advise patients to adhere strictly to these dosing guidelines to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

It is imperative that this product 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, the use of this product is contraindicated 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 there is uncertainty regarding the presence of an MAOI in their current prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they experience a cough accompanied by excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and contact their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is essential to ensure patient safety and appropriate management of the situation.

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 individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is imperative that patients do not use this medication if they are on an MAOI or for at least two weeks after stopping such treatment, as this could lead to significant health risks.

Common adverse reactions may include a persistent cough. Patients are advised to stop using the medication and consult a healthcare professional if their cough lasts 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.

Additionally, patients should seek medical advice before using this medication if they have a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center. This ensures that any potential complications are addressed promptly and effectively.

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 within 2 weeks of discontinuing an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Cough Plus Chest Congestion Dm (dextromethorphan hydrobromide and guaifenesin). 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. There are no established safety or efficacy profiles for children in this age group, and therefore, it is contraindicated for use in this population.

Geriatric Use

Elderly patients may utilize this adult 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 2 softgels every 4 hours.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as age-related physiological changes may affect drug metabolism and clearance. It is advisable to monitor elderly patients closely for any adverse effects or changes in therapeutic response, and to consider potential dose adjustments based on individual patient factors, including renal and hepatic function.

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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 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 distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported regarding animal pharmacology and toxicology.

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, pruritus, and urticaria.

Patient Counseling

Healthcare providers should advise patients to keep the medication 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 must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should also counsel patients 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 condition.

Additionally, patients should be encouraged to seek medical advice before using the medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Maximum Strength Cough Plus Chest Congestion Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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