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Cold and Flu

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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 2021
Label revision date
December 12, 2025
Manufacturer
Rite Aid Corporation
Registration number
M012
NDC root
11822-6179
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Maximum Strength Cold & Flu is a medication designed to provide multi-symptom relief for common cold and flu symptoms. It contains a combination of Acetaminophen (a pain reliever and fever reducer), Dextromethorphan HBr (a cough suppressant), Guaifenesin (an expectorant that helps loosen mucus), and Phenylephrine HCl (a decongestant). This formulation temporarily alleviates symptoms such as nasal congestion, sore throat, cough, headache, minor aches and pains, and sinus pressure, while also helping to reduce fever.

In addition to relieving these symptoms, Guaifenesin works by thinning bronchial secretions, making coughs more productive by clearing mucus from the airways. This makes Maximum Strength Cold & Flu a helpful option when you're feeling under the weather and need relief from multiple symptoms.

Uses

This medication is designed to help you feel better when you're dealing with common cold and flu symptoms. It can temporarily relieve nasal congestion, sore throat, cough, headache, minor aches and pains, as well as sinus congestion and pressure.

Additionally, it works to loosen phlegm (a type of mucus) and thin bronchial secretions, making it easier to clear out your airways and have more productive coughs. If you're experiencing a fever, this medication can also help to temporarily reduce it, providing you with some much-needed comfort.

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. However, make sure not to exceed 12 caplets in a 24-hour period.

If you are caring for children under 12 years old, please do not use this medication for them. Always remember to take only the directed amount to avoid any potential risks.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure about a medication, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. It's also important not to use this product if you have ever had an allergic reaction to it or any of its ingredients. Lastly, make sure to follow the recommended dosage and do not exceed it.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg 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 blisters, rash, or skin reddening. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should stop using this product and consult a doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, nasal congestion, or cough worsens or lasts more than seven days, or if you develop a fever that lasts more than three days. Additionally, if you have liver disease, diabetes, heart disease, or other specific health conditions, it's important to talk to your doctor before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters or rashes. If you notice 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 right away.

Before using this product, talk to your doctor if you have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent cough. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. In case of an accidental overdose, seek emergency medical help or contact a Poison Control Center immediately, even if you don’t notice any symptoms.

You should stop using this product and call your doctor if you experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if you notice redness or swelling; if fever worsens or lasts more than three days; if new symptoms develop; or if a cough returns with a rash or headache that lasts. These could indicate a more serious condition.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly 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

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years old. For those aged 12 and older, the recommended dosage is 2 caplets every 4 hours, but be sure not to exceed a total of 12 caplets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

If you are an older adult or a caregiver, it's important to know that there are no specific dosage adjustments or safety concerns mentioned for elderly patients regarding this medication. However, it's always wise to consult with a doctor before starting any new treatment, especially if you or the person you are caring for has conditions like liver disease, diabetes, thyroid disease, heart disease, high blood pressure, or difficulty urinating due to an enlarged prostate. These factors can be particularly relevant for older adults and may influence how the medication works for them.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Before using this product, you should consult your doctor, especially if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety by managing your treatment plan effectively. Always keep an open line of communication about all the medications you are taking to avoid any potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the outer package is intact before use. If the package is opened or the blister is torn or broken, do not use it. You can find important information like the expiration date and lot number on the end flap of the package.

For proper storage, keep the product at a temperature of 25°C (77°F). It’s okay if the temperature occasionally varies between 15°C and 30°C (59°F to 86°F), but try to avoid prolonged exposure to temperatures outside this range. Following these guidelines will help maintain the quality and safety of the product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an accidental overdose, seek medical help immediately or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Additionally, if you're concerned about medicine abuse among teens, you can find helpful resources at www.StopMedicineAbuse.org.

FAQ

What is Maximum Strength Cold & Flu?

Maximum Strength Cold & Flu is a medication that contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, providing multi-symptom relief for cold and flu symptoms.

What symptoms does this medication relieve?

It temporarily relieves nasal congestion, sore throat, cough, headache, minor aches and pains, and sinus congestion and pressure.

How does it help with coughs?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

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

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

Are there any contraindications for this medication?

Do not use this product with any other drug containing acetaminophen, if you are taking a prescription monoamine oxidase inhibitor (MAOI), or if you have had an allergic reaction to this product or its ingredients.

What should I do if I experience severe skin reactions?

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

What should I do in case of an accidental overdose?

Get medical help or contact a Poison Control Center right away, as prompt medical attention is critical.

Is it safe to use if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What are the storage instructions for this medication?

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

What should I do if my symptoms worsen or new symptoms occur?

Stop use and consult a doctor if symptoms worsen, last more than 7 days, or if new symptoms occur.

Packaging Info

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Flu.
Details

Drug Information (PDF)

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

View product document (PDF)

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, sore throat, cough, headache, minor aches and pains, and sinus congestion and pressure. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and enhancing the productivity of coughs. This drug also 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. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 4 hours as needed. It is imperative that patients do not exceed 12 caplets within a 24-hour period.

The use of this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients are informed of these guidelines to prevent potential overdose and ensure safe administration.

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.

  • Concurrent use with a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

  • History of allergic reaction to this product or any of its ingredients, which may result in severe hypersensitivity reactions.

Additionally, it is advised not to exceed the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as blisters, rash, or skin reddening. Should any of these symptoms arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product.

Emergency Medical Help In the event of an accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if redness or swelling occurs; if fever worsens or lasts more than three days; if new symptoms develop; or if a cough recurs with a rash or headache that persists. 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 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients should stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if redness or swelling is present; if fever worsens or lasts more than three days; if new symptoms arise; or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have liver disease, diabetes, thyroid disease, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent or 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.

Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of bleeding complications. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 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 dosage not exceeding 12 caplets in any 24-hour period. Caution should be exercised to adhere to the specified dosing guidelines to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients when prescribing this medication.

General considerations indicate that there are no special precautions or recommendations specifically tailored for elderly patients. Nonetheless, it is advisable for healthcare providers to consult with a physician prior to use if the patient has underlying conditions such as liver disease, diabetes, thyroid disease, heart disease, high blood pressure, or difficulty in urination due to prostate gland enlargement. These conditions may be particularly relevant in the geriatric population and warrant careful evaluation to ensure safe and effective use of the medication.

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 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 drug insert 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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations, as early intervention can significantly impact patient outcomes. It is essential to assess the patient's condition thoroughly and initiate appropriate management protocols as dictated by the severity of the overdose and the specific substance involved.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions associated with acetaminophen. These reactions include symptoms such as blisters, rash, and skin reddening. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an accidental overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health complications associated with overdose.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken. Healthcare professionals should check the end flap for the expiration date and lot number to ensure product integrity.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15°C to 30°C (59°F to 86°F). Proper handling and storage are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding before use. Additionally, it is crucial to keep the medication out of reach of children. In the event of an accidental overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

For information regarding the potential for medicine abuse among teens, resources are available at www.StopMedicineAbuse.org. No further details are provided regarding laboratory tests or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.

Learn more in our Editorial Policy

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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.