Severe Congestion and Cough Max

Description

AP SAFE® is a maximum strength formulation designed for the relief of cough and congestion. Each 6 FL OZ (177 mL) bottle contains a combination of active ingredients: Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant that thins and loosens mucus; and Phenylephrine HCl, a nasal decongestant. This product is intended for use by adults aged 12 and over. The National Drug Code (NDC) for this product is 76281-517-25. It is manufactured by AptaPharma Inc., located at 1533 Union Ave., Pennsauken, NJ 08110. This product is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of Mucinex® FAST-MAX™ Severe Congestion & Cough. Users are advised not to use the product if the printed seal under the cap is torn or missing.

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 should advise patients to take the medication only as recommended. It is essential to utilize the provided dosage cup for accurate measurement, with 1 mL equating to one milliliter. Patients must not exceed 6 doses within any 24-hour period to avoid potential overdose.

For adults and children aged 12 years and older, the recommended dosage is 20 mL administered every 4 hours as needed. The use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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 at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

This product is not recommended for children under 12 years of age.

Healthcare professionals should exercise caution and recommend that patients seek medical advice 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, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare provider before use. It is imperative that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to discontinue use and contact their 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 with fever, rash, or persistent headache, medical advice should be sought, as these may indicate a serious condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should consult a healthcare professional if they are uncertain whether their prescription includes an MAOI. Additionally, this product is not recommended for children under 12 years of age.

Before using this product, patients with certain medical conditions should seek medical advice. These conditions include heart disease, thyroid disease, high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, and chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing a cough with excessive phlegm should also consult a healthcare provider prior to use.

While using this product, it is crucial for patients to adhere strictly to the recommended dosage and not exceed the directed amount. Patients should 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 recurs with fever, rash, or persistent headache, medical advice should be sought, as these may indicate a serious condition.

Pregnant or breastfeeding patients are advised to consult a healthcare professional before using this product to ensure safety for both themselves and their child.

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, psychiatric disorders, emotional 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 Severe Congestion and Cough Max (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 therefore, its use is contraindicated in children within this age range.

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 potential 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. 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 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

Overdosage of this product can lead to serious health consequences. It is imperative that healthcare professionals advise patients to adhere strictly to the recommended dosage guidelines. Exceeding the directed dosage may result in adverse effects that could compromise patient safety.

In the event of suspected overdosage, it is crucial to monitor the patient for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific product and the extent of the excess dosage. Healthcare providers should be vigilant in assessing the patient's condition and may need to implement appropriate management strategies.

Recommended actions in the case of overdosage include immediate medical evaluation and intervention. Healthcare professionals should consider contacting a poison control center for guidance on the management of the specific symptoms presented. Supportive care may be necessary, and symptomatic treatment should be initiated as required.

In summary, adherence to the prescribed dosage is essential to prevent overdosage and its associated risks. Healthcare professionals play a vital role in educating patients about the importance of following dosage instructions and in managing any incidents of overdosage effectively.

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

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

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 permitted, 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 Severe Congestion and Cough Max, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)