Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Maximum Strenght Day Cold and Flu Formula

Last content change checked dailysee data sync status

Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
February 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
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 2020
Label revision date
February 15, 2025
Manufacturer
FAMILY DOLLAR
Registration number
M012
NDC root
55319-933
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to temporarily relieve symptoms associated with a cold or flu, helping you feel more comfortable when you're not feeling well. It can help alleviate minor aches and pains, headaches, coughs, sore throats, and nasal and sinus congestion. Additionally, it works to temporarily reduce fever, providing you with some relief during your illness.

Uses

This medication is designed to help you feel better when you're dealing with the discomfort of a cold or flu. It can temporarily relieve minor aches and pains, headaches, coughs, sore throats, and nasal and sinus congestion. If you're also experiencing a fever, this medication can help reduce it as well.

You can rely on this treatment to ease your symptoms and help you get through your day a little more comfortably.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage carefully. For adults and children aged 12 years and older, you should take 2 softgels with a glass of water every 4 hours. However, make sure not to exceed 10 softgels in a 24-hour period unless directed by your doctor.

If you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group. Always remember to stick to the recommended dose to ensure your safety and effectiveness of the treatment.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware of some important warnings related to this medication. Taking more than 4,000 mg of acetaminophen in 24 hours, using it with other products containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Additionally, acetaminophen may cause serious allergic reactions, which can include symptoms like skin reddening, blisters, rash, hives, facial swelling, wheezing (asthma), or even shock. If you experience any of these reactions, stop using the medication and seek medical help immediately. If you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor right away.

Warnings and Precautions

It's important to be aware of some serious warnings when using this product, which contains acetaminophen. Taking more than 4,000 mg 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. Additionally, be cautious of potential allergic reactions, which may include symptoms like skin reddening, blisters, rash, hives, facial swelling, wheezing, or shock. If you experience any of these symptoms, 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. In case of an overdose, it's crucial to get emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if you don't notice any symptoms. Regular lab tests may be necessary to monitor your liver function while using this medication, so be sure to follow your healthcare provider's recommendations.

Overdose

Taking too much acetaminophen can lead to serious liver damage. You should be cautious not to exceed 4,000 mg in a 24-hour period. Additionally, combining acetaminophen with other medications that also contain acetaminophen can increase your risk of liver damage. If you regularly consume three or more alcoholic drinks each day, using acetaminophen can further heighten this risk.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). It’s important to seek immediate medical help if you experience any of these symptoms or if you believe you have taken too much acetaminophen. Always prioritize your health and safety by consulting a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings about using this product during pregnancy. The information available does not mention any safety concerns, contraindications (conditions that would make the use of the product inadvisable), or the need for dosage adjustments for pregnant individuals. Additionally, there are no special precautions outlined for use during this time.

As always, it's best to consult with your healthcare provider before starting any new medication or treatment while pregnant to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to know that this medication should not be given to children under 12 years old. For those aged 12 and older, the recommended dosage is 2 softgels taken with water every 4 hours, but you should not exceed 10 capsules in a 24-hour period unless directed by a doctor.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is essential, even if there are no noticeable signs or symptoms.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. Additionally, combining this product with other medications that also contain acetaminophen can increase your risk.

You should also be aware that consuming three or more alcoholic drinks each day while using this product can further harm your liver. Always consult with your healthcare provider for personalized advice and to ensure safe use, especially if you have existing liver conditions.

Drug Interactions

It's important to be aware of potential interactions when taking medications. For instance, taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. Additionally, combining acetaminophen with other medications that also contain acetaminophen can increase this risk. If you consume three or more alcoholic drinks daily while using acetaminophen, you may also face serious liver issues.

Always discuss your medications and any alcohol consumption with your healthcare provider to ensure your safety and well-being. They can help you understand the risks and make informed decisions about your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to maintain its integrity and protect it from light, which can affect its quality.

Once you open the container, please remember to discard it after use to ensure safety and effectiveness. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms of overdose.

FAQ

What symptoms does this drug relieve?

This drug temporarily relieves symptoms due to a cold or flu, including minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion.

How does this drug affect fever?

The drug temporarily reduces fever.

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

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 10 capsules in 24 hours or as directed by a doctor.

Are there any warnings associated with this drug?

Yes, severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience an allergic reaction?

If you experience a skin or general allergic reaction, stop use and seek medical help right away.

Is this drug safe for children under 12?

No, this drug should not be used in children under 12 years.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Is there any information regarding use during pregnancy?

There are no specific statements regarding the use of this product during pregnancy in the provided text.

What should I do if my sore throat is severe?

If your sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Packaging Info

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

Packaging configurations for Maximum Strenght Day Cold and Flu Formula.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates minor aches and pains, headache, cough, sore throat, and nasal and sinus congestion. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 softgels with water every 4 hours as needed. The total dosage must not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

It is important to note that this medication is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that patients adhere to the recommended dosing guidelines to avoid potential overdose.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. 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 drinks daily while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

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

In cases of suspected overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to stop taking the product and contact their healthcare provider if any signs of a skin or general allergic reaction occur.

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 or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Drug Interactions

Severe liver damage may occur with the use of acetaminophen under certain conditions. It is critical to adhere to the following guidelines to mitigate the risk of hepatotoxicity:

  • Acetaminophen Dosage: The maximum recommended dosage of acetaminophen should not exceed 4,000 mg within a 24-hour period. Exceeding this limit significantly increases the risk of severe liver damage.

  • Combination with Other Acetaminophen-Containing Products: Concurrent use of acetaminophen with other medications that also contain acetaminophen can lead to severe liver damage. Patients should be advised to carefully check the ingredients of all medications to avoid unintentional overdose.

  • Alcohol Consumption: The risk of severe liver damage is heightened in individuals who consume three or more alcoholic drinks daily while using acetaminophen. It is advisable for patients to limit or avoid alcohol intake during treatment with this medication.

No specific drug or laboratory test interactions have been identified in the provided data. Regular monitoring of liver function may be warranted in patients at risk for liver damage, particularly those who exceed recommended dosages or consume alcohol.

Packaging & NDC

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

Packaging configurations for Maximum Strenght Day Cold and Flu Formula.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For individuals aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 capsules in a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The available data does not indicate any safety concerns or contraindications related to pregnancy. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions regarding use during pregnancy. Healthcare professionals should consider the absence of specific information when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations concerning lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Furthermore, patients with compromised liver function are advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product. Monitoring of liver function is recommended in patients with existing liver conditions or those who are at increased risk for hepatic impairment. Regular assessment of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of potential hepatotoxicity.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken concurrently with other medications that also contain acetaminophen.

Furthermore, the consumption of three or more alcoholic beverages daily while using acetaminophen can exacerbate the risk of severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should assess the patient's condition and consider the need for liver function tests and other relevant diagnostic evaluations. Prompt intervention is crucial to mitigate potential liver injury and ensure appropriate management of the overdosage.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions and severe allergic reactions have been reported. Symptoms indicative of severe allergic reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay.

Providers should also stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can help ensure the safety and well-being of patients in case of an emergency.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Maximum Strenght Day Cold and Flu Formula, 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 Maximum Strenght Day Cold and Flu Formula, 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

Last AI update:

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.