Maxium Strength Severe Congestion and Cough Max

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions, specifically to help loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes. It is also indicated for the temporary relief of cough due to minor throat and bronchial irritation, as well as nasal congestion occurring with a cold.

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

Dosage and Administration

The medication should be taken only as recommended. For administration, a dosage cup should be utilized to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses within a 24-hour period. It is important to adhere to this dosing schedule to avoid exceeding the recommended limits.

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 essential to adhere to the recommended dosage guidelines, as exceeding the directed use may lead to adverse effects.

Warnings and Precautions

The product must not be used if the printed seal under the cap is torn or missing. It is contraindicated for children under 12 years of age. Additionally, the product should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Use is also prohibited for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medication.

General precautions include ensuring that the product is kept 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.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by a fever, or if a cough recurs or presents with fever, rash, or persistent headache, these may indicate a serious condition requiring medical evaluation.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop 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 recurs or occurs with fever, rash, or persistent headache, these may indicate a serious condition requiring further evaluation.

Common adverse reactions may include those related to the underlying health conditions of patients. It is important for patients to inform their healthcare provider before using this product if they have a history of heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use, particularly if the cough is productive with excessive phlegm.

Warnings are in place to ensure safe use of the product. Patients should not use the product if the printed seal under the cap is torn or missing, or if they are under 12 years of age. Furthermore, the product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications, as this could lead to serious interactions. If patients are uncertain whether their prescription includes an MAOI, they should consult a doctor or pharmacist before taking this product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Maxium Strength Severe Congestion and Cough Max (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. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. Safety and efficacy have not been established in children younger than 12 years, and therefore, use in this population is contraindicated.

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 adverse effects or changes in efficacy, 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. It is important to assess the potential risks and benefits associated with its 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

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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These reactions may occur with the use of the product.

Patient Counseling

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

Patients should be instructed to stop using the product 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.

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

Healthcare providers should also encourage patients to consult a doctor before using this product 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° to 30°C (59° to 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 product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)