Max Cold, Flu, and Sore Throat

Description

This product is a maximum strength formulation indicated for the relief of symptoms associated with cold, flu, and sore throat. It contains a combination of active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. The product is packaged in a 6 fluid ounce (117 mL) bottle and is marketed under the H E B® brand, with the National Drug Code (NDC) 37808-316-25. It is comparable to Mucinex® FAST-MAX™.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions to facilitate drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children 12 years and older are to receive a dosage of 20 mL every 4 hours. It is imperative that this medication is not administered to children under 12 years of age.

The recommended route of administration is oral, and healthcare professionals should ensure that the dosage is taken as directed, adhering to the specified frequency to maintain therapeutic effectiveness.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic beverages daily while using this product.

Patients should be informed of the potential for severe allergic reactions associated with acetaminophen. Symptoms indicative of a serious skin reaction may include skin reddening, blisters, or rash. In the event of such symptoms, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is advised.

In cases of suspected overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if redness or swelling occurs, or if symptoms do not improve within seven days or are accompanied by fever, further evaluation is necessary. A worsening fever lasting more than three days, the emergence of new symptoms, or a cough persisting beyond seven days—especially if it recurs or is associated with fever, rash, or persistent headache—may indicate a serious underlying condition that requires medical assessment.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

Overdose of acetaminophen can lead to significant liver damage. Patients who suspect an overdose should seek medical help or contact the Poison Control Center without delay, as timely medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients are also advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if redness or swelling occurs; if symptoms do not improve within seven days or are accompanied by fever; if fever worsens or persists for more than three days; if new symptoms arise; or if a cough lasts more than seven days, recurs, or occurs with fever, rash, or persistent headache, as these may indicate a serious condition.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

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

Packaging & NDC

Below are the non-prescription pack sizes of Max 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 medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 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 should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that contain acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be closely monitored for signs of liver damage and advised to adhere strictly to the recommended dosage guidelines. It is recommended that healthcare providers assess liver function prior to initiating treatment and consider dosage adjustments as necessary based on the severity of hepatic impairment.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. It is imperative that healthcare professionals recognize the seriousness of this condition and act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact the Poison Control Center without delay. This is essential for both adults and children, as prompt intervention can mitigate potential complications.

Even in the absence of noticeable signs or symptoms, the need for quick medical attention cannot be overstated. Healthcare providers should ensure that patients and caregivers are aware of these critical steps to take in the event of an overdose, emphasizing the importance of vigilance and timely response.

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

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

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

Patients should be informed 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 consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

This medication is not recommended for children under 12 years of age. Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if they notice any redness or swelling, if symptoms do not improve within 7 days, or if symptoms are accompanied by a fever. Patients should also be instructed to seek medical attention if a fever worsens or persists for more than 3 days, or if new symptoms develop.

Patients should be made aware that if a cough lasts more than 7 days, returns, or occurs with fever, rash, or persistent headache, they should consult a doctor, as these may indicate a serious condition. When using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25° C (68° to 77° F). It is imperative that the product is not refrigerated to maintain its integrity. Proper handling and storage conditions must be adhered to in order to ensure optimal efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should counsel patients on the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Additionally, patients who are pregnant or breastfeeding should consult a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)