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Mucinex Fast-Max Cold and Flu

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Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
March 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
March 31, 2025
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
72854-161
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

This medication is designed to temporarily relieve symptoms associated with the common cold and flu. It can help ease a variety of discomforts, including cough caused by minor throat and bronchial irritation, as well as the intensity and impulse to cough that may disrupt your sleep. Additionally, it addresses minor aches and pains, sore throat, headache, and can temporarily reduce fever.

By targeting these symptoms, this drug aims to provide you with some comfort during your illness, allowing you to feel a bit better while your body fights off the infection.

Uses

This medication is designed to help you feel better when you're dealing with common cold and flu symptoms. It can temporarily relieve a variety of discomforts, including cough caused by minor throat and bronchial irritation, which can happen due to the cold or from inhaling irritants. If you're struggling with a persistent cough that keeps you awake, this medication can help reduce that impulse, allowing you to get some rest.

In addition to easing your cough, it can also help with minor aches and pains, soothe a sore throat, alleviate headaches, and temporarily lower fever. By addressing these symptoms, the medication aims to make you feel more comfortable while you recover.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety. For adults and children aged 12 years and older, you should take 2 caplets every 4 hours as needed, but make sure not to exceed 12 caplets in a 24-hour period. This means you can take the medication multiple times throughout the day, but always stick to the recommended amount.

If you are caring for younger children, please note that this medication is not suitable for anyone under 12 years of age. Always remember to adhere to the directions provided to avoid any potential overdose, which can be harmful. If you have any questions or concerns about taking this medication, consult with a healthcare professional.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 12 caplets in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

If you have liver disease, a chronic cough, or are taking certain medications for depression or Parkinson’s disease, consult your doctor before using this product. You should also stop use and contact a doctor if your pain or cough worsens or lasts longer than specified durations, if you develop new symptoms, or if you experience a cough accompanied by a rash or headache. In case of overdose, which can cause liver damage, seek medical attention immediately, even if you do not notice any symptoms.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 12 caplets in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin issues, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, avoid combining it with any other medications that contain acetaminophen. If you are taking a prescription monoamine oxidase inhibitor (MAOI) or have liver disease, chronic cough, or are on blood thinners like warfarin, consult your doctor first. Always follow the dosage instructions carefully and do not exceed the recommended amount.

You should stop taking this product and call your doctor if your pain or cough worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any redness or swelling. New symptoms or a cough that returns with a rash or headache could indicate a serious condition. In case of overdose, seek emergency medical help or contact a Poison Control Center immediately, as quick attention is crucial for both adults and children.

Overdose

Taking more than the recommended dose of this medication can lead to serious health issues, including liver damage. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center.

Even if you don’t notice any signs or symptoms, quick medical attention is crucial for both adults and children. Remember, acting fast can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering medication for children. If your child is under 12 years old, you should not use this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 4 hours, but be sure not to exceed 12 caplets in a 24-hour period.

Always keep this medication out of reach of younger children, and remember that if an overdose occurs, it's crucial to seek medical help immediately, even if there are no noticeable symptoms. Your child's safety is the top priority.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always ensure that your doctor is aware of all medications being taken, as older adults often have different health considerations that may affect how a drug works. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

This product contains acetaminophen, which can be harmful to your liver, especially if you have liver problems. It's important to avoid taking more than 12 caplets in a 24-hour period, as this is the maximum daily amount. You should also refrain from using other medications that contain acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

If you have liver disease, please consult your doctor before using this medication. Be aware that taking more than the recommended dose can lead to serious liver damage. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if there are no immediate symptoms.

Drug Interactions

It's important to be cautious when taking this medication, especially regarding potential interactions with other drugs. You should avoid using it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or Parkinson’s disease—or have taken one in the last two weeks, you should not use this medication.

Before starting this medication, it's also wise to consult with your doctor or pharmacist if you are taking warfarin, a blood-thinning medication. Discussing all your current medications and any health conditions with your healthcare provider can help ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What symptoms does this drug relieve?

This drug temporarily relieves common cold and flu symptoms, including cough, minor aches and pains, sore throat, headache, and fever.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years of age and over should take 2 caplets every 4 hours, not exceeding 12 caplets in a 24-hour period.

Can children under 12 use this medication?

No, children under 12 years of age should not use this medication.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as reddening, blisters, or rash, stop use and seek medical help immediately.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

Are there any warnings associated with this drug?

Yes, there are liver warnings due to the presence of acetaminophen, and you should avoid taking it with other acetaminophen-containing drugs or if you consume 3 or more alcoholic drinks daily.

Should I consult a doctor before using this drug?

Yes, you should ask a doctor before use if you have liver disease, a persistent cough, or if you are taking blood thinners like warfarin.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

Packaging Info

Below are the non-prescription pack sizes of Mucinex Fast-Max Cold and Flu (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Fast-Max Cold and Flu.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, which may occur as a result of the common cold or exposure to inhaled irritants. Additionally, it addresses the intensity of coughing and the impulse to cough, facilitating sleep. The drug also provides relief from minor aches and pains, sore throat, headache, and temporarily reduces fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is 12 caplets within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours as needed. It is imperative that patients do not exceed the specified dosage.

This medication is not indicated for use in 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

This product contains acetaminophen, which poses a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is 12 caplets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions may occur in individuals allergic to acetaminophen. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any of these symptoms arise, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General precautions should be emphasized. Patients must not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be advised to consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure about their medications.

Before using this product, patients should seek medical advice if they have liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm. Furthermore, patients taking the anticoagulant warfarin should consult a healthcare professional prior to use.

Patients must adhere strictly to the recommended dosage and should be instructed to stop taking the product and contact their doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 the maximum daily dosage of 12 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may experience liver damage. Immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients are advised to discontinue use and seek medical assistance promptly.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional without delay.

Patients are advised against using this product concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the past two weeks should not use this product.

Before using this product, patients should consult a doctor if they have liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm.

Patients should discontinue use and seek medical advice if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this medication with any other drug 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), which includes certain medications for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

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 increase the risk of bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Fast-Max Cold and Flu (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Fast-Max Cold and Flu.
Details

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 2 caplets every 4 hours, with a maximum daily limit of 12 caplets within a 24-hour period.

Healthcare professionals should be aware of the critical need for quick medical attention in cases of overdose, which applies 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 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

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 should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere strictly to the recommended dosage guidelines. The maximum daily amount for this product is 12 caplets within a 24-hour period. Exceeding this limit, taking other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product may significantly increase the risk of liver damage.

Patients with liver disease are advised to consult a healthcare professional before using this product. In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical attention is necessary. Quick intervention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. Monitoring liver function and being vigilant about the signs of liver damage is essential for patients with compromised liver function.

Overdosage

In the event of an overdose, defined as the ingestion of a quantity exceeding the recommended dose, there is a significant risk of liver damage. This potential complication underscores the importance of prompt medical intervention.

Healthcare professionals are advised to seek immediate medical assistance or contact a Poison Control Center if an overdose is suspected. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can be critical in mitigating the effects of an overdose and ensuring appropriate management.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mucinex Fast-Max Cold and Flu, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.