H E B Max Severe Congestion and Cough

Description

This product is a maximum strength formulation designed for the relief of severe congestion and cough, comparable to Mucinex® FAST-MAX™. It contains Dextromethorphan HBr as a cough suppressant, Guaifenesin as an expectorant, and Phenylephrine HCl as a nasal decongestant. The product effectively alleviates cough, thins and loosens mucus, and addresses nasal and chest congestion. It is intended for use by adults and individuals aged 12 and over. The product is packaged in a 6 FL OZ (177 mL) bottle and is manufactured with pride and care for H-E-B® in San Antonio, Texas, 78204. The National Drug Code (NDC) for this product is 37808-317-25. This product is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of Mucinex® FAST-MAX™ Severe Congestion & Cough.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, including cough due to minor throat and bronchial irritation and nasal congestion. 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

Healthcare professionals are advised to administer the medication strictly as recommended. The use of a dosage cup is essential for accurate measurement, with the volume expressed in milliliters (mL).

For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

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

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage. Adherence to the prescribed dosage is essential to avoid potential adverse effects associated with overuse.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain 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. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

This product is not recommended for children under 12 years of age. 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 with a Poison Control Center is advised.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, or if a cough recurs or is associated with fever, rash, or a persistent headache, it is crucial to seek medical attention, as these may indicate a serious underlying condition.

In cases of overdose, prompt medical help should be obtained, or a Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks. Additionally, this product is not recommended for children under 12 years of age.

Common adverse reactions that warrant immediate medical attention include nervousness, dizziness, and sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms arise. Furthermore, if symptoms do not improve within 7 days or are accompanied by a fever, or if a cough recurs with fever, rash, or persistent headache, it is crucial to seek medical advice, as these may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare provider if they have a history of heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. Caution is also advised for those with a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, as well as for individuals experiencing a cough with excessive phlegm.

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 H E B Max Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated. Healthcare professionals are advised to consider alternative treatments for this age group.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older. It is essential for geriatric patients to consult a healthcare provider prior to use if they have a history of heart disease, thyroid disease, high blood pressure, diabetes, or urinary difficulties due to an enlarged prostate gland.

Dosage should not exceed the recommended amount, and patients must adhere strictly to the directed usage. Geriatric patients are advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, medical consultation is necessary.

Patients should also stop using the product and consult a healthcare provider if a cough recurs or is associated with fever, rash, or a persistent headache, as these may indicate a more serious underlying condition. Monitoring for these symptoms is particularly important in the elderly population to ensure safety and appropriate management of their health.

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 maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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

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 these patients to ensure safety and efficacy.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions associated with the use of the product. These include nervousness, dizziness, sleeplessness, rash, persistent headache, and fever. While these reactions have been reported voluntarily or through surveillance programs, their occurrence in patients may indicate the presence of a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, or if a cough returns or occurs with fever, rash, or persistent headache, they should seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage.

Healthcare providers should also encourage patients to consult a doctor prior to use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30° C (59-86° F). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for H E B Max Severe Congestion and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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