Maximum Strength Cold Flu and Sore Throat

Description

NDC# 30142-731-06. This product is a maximum strength formulation designed for the relief of symptoms associated with cold, flu, and sore throat. It contains acetaminophen as a pain reliever and fever reducer, dextromethorphan HBr as a cough suppressant, guaifenesin as an expectorant, and phenylephrine HCl as a nasal decongestant. The formulation effectively relieves headache, fever, sore throat, nasal and chest congestion, and controls cough while thinning and loosening mucus. It is intended for use by individuals aged 12 years and older. The product is presented in a 6 FL OZ (180 mL) dosage form. The packaging includes a tamper-evident seal; do not use if the printed seal under the cap is broken or missing. This product is distributed by a company that is not affiliated with Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, nasal congestion, minor aches and pains, sore throat, headache, stuffy nose, and sinus congestion and pressure. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The formulation aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits to avoid the risk of overdose.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that the dosing cup is used exclusively for this product and not with any other medications.

For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should ensure that patients understand the importance of not exceeding 6 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Furthermore, it is essential to adhere to the recommended dosage and not exceed the directed amount.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be advised to consult a doctor or pharmacist before using this product if they are currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, regardless of whether signs or symptoms are present, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with fever, rash, or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 6 doses in a 24-hour period, which is the maximum daily amount, or if they take this product in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if redness or swelling is present; if new symptoms arise; or if a cough recurs with fever, rash, or headache that lasts. These symptoms could indicate a serious condition.

It is critical to note that taking more than the recommended dose may lead to overdose and subsequent liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Cold Flu and Sore Throat (acetaminophen, 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 use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL in the dosing cup provided every 4 hours.

Healthcare professionals should be aware of the critical need for quick medical attention in cases of overdose, applicable to both adults and children, even if no signs or symptoms are immediately apparent. It is essential to keep this medication out of reach of children to prevent accidental ingestion.

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 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 on 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 mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of adverse effects.

The maximum recommended dosage is 6 doses within a 24-hour period. Patients with compromised liver function should avoid exceeding this limit, as doing so may significantly increase the risk of liver damage. Additionally, patients should not take this product concurrently with other medications that contain acetaminophen, as this can further elevate the risk of hepatotoxicity.

Consumption of alcohol should also be approached with caution. Patients are advised to limit their intake to fewer than 3 alcoholic drinks per day while using this product, as higher levels of alcohol consumption can exacerbate liver damage.

Patients with a history of liver disease should consult a healthcare professional before using this product. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance is essential. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance, as prompt medical attention is critical for both adults and children, regardless of the presence of symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center immediately at 1-800-222-1222. Prompt action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be apparent, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should educate patients on the necessity of monitoring for any unusual signs or symptoms following an overdose, even if they initially appear asymptomatic.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. The involvement of poison control experts can provide additional guidance on the necessary steps to take in managing the overdose effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, patients must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider, as these may indicate a serious condition. Patients should be particularly vigilant if a cough returns or occurs alongside fever, rash, or a headache that lasts.

When using this product, patients must adhere strictly to the directed dosage. Healthcare providers should recommend that patients consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence. It is essential to inspect the printed seal under the cap; do not use the product if this seal is broken or missing.

For optimal storage, the product should be kept at room temperature. It is important to note that refrigeration is not permitted, as this may compromise the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dose of 20 mL every 4 hours for adults and children aged 12 years and older, or as directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Maximum Strength Cold Flu and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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