Maximum Strength Mucus Relief Cold, Flu and Sore Throat

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, sore throat, and headache. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The drug also 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 potential overdose (refer to Overdose Warning).

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, 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.

In any case, patients should not exceed 6 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, due to the potential for serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. Specifically, patients should not exceed 6 doses within a 24-hour period, which constitutes the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can further increase the risk of liver damage. Additionally, patients should be informed that consuming 3 or more alcoholic drinks daily while using this product may exacerbate the risk of liver injury.

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 be instructed to consult a healthcare provider promptly.

Patients should be advised to discontinue use and seek medical advice if they experience any of the following symptoms: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; or a cough that recurs or occurs with a rash or persistent headache. These symptoms may indicate a serious underlying condition.

Healthcare professionals should also inquire about the following conditions before recommending this product: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, and persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with a cough that produces excessive phlegm (mucus) should be evaluated before use.

Furthermore, it is essential to advise patients to consult a doctor or pharmacist prior to using this product if they are currently taking the anticoagulant medication warfarin, as interactions may occur. Regular monitoring of liver function and other relevant parameters may be warranted in patients with pre-existing conditions or those taking concomitant medications.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 6 doses in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists for more than 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland. Those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough that occurs with excessive phlegm (mucus) should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen is contraindicated due to the potential for increased risk of severe liver damage.

Additionally, caution is advised when using this medication in conjunction with warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted in such cases to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Mucus Relief Cold, Flu and Sore Throat (acetaminophen, dextromethorphan hydrobromide, 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 product. For those aged 12 years and older, the recommended dosage is 20 mL, administered using the dosing cup provided, every 4 hours as needed.

Caution is advised for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks following the discontinuation of an MAOI, as the use of this product is contraindicated in these circumstances.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this product, as no safety concerns have been identified in the provided information. However, caution is advised when administering the product to individuals with pre-existing conditions that are commonly found in geriatric populations, such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

Healthcare providers should closely monitor elderly patients for any potential adverse effects, particularly in the presence of these conditions. It is recommended that patients consult their healthcare provider prior to use if they have any of the aforementioned health issues, as these may influence the safety and efficacy of the treatment in this demographic.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 alcoholic drinks daily while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Administration of more than six doses within a 24-hour period, which constitutes the maximum daily allowance, can lead to severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a substantial risk for severe liver damage. It is crucial for healthcare providers to assess a patient's complete medication history to prevent potential interactions that could exacerbate liver toxicity.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of severe liver damage. Healthcare professionals should counsel patients on the dangers of alcohol consumption during treatment and consider alternative therapies for those with a history of alcohol use.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Prompt intervention is essential to mitigate the risk of irreversible liver injury.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, reports of pain, nasal congestion, and cough worsening or persisting for more than 7 days have been noted. Instances of fever worsening or lasting more than 3 days, as well as redness or swelling, have also been documented. New symptoms occurring, along with cough returning or occurring in conjunction with rash or persistent headache, have been observed in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. Furthermore, patients should be informed to stop use and consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. Healthcare providers should encourage patients to 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. Additionally, 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 with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30°C (59-86°F). It is important to note that refrigeration is not permitted, as the product must not be exposed to temperatures outside the specified range. Proper handling and storage conditions are essential to maintain 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 advise patients to consult a health professional if they are pregnant or breastfeeding and to keep the medication out of reach of children.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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