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Daytime Cold and Flu Relief

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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 2025
Label revision date
March 3, 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 2025
Label revision date
March 3, 2025
Manufacturer
Bi-Mart
Registration number
M012
NDC root
37835-520
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

This medication is designed to temporarily relieve symptoms associated with the common cold and flu. It contains three active ingredients: acetaminophen (a pain reliever and fever reducer), phenylephrine HCl (a decongestant that helps relieve nasal congestion), and dextromethorphan HBr (a cough suppressant that helps reduce the urge to cough).

You can use this product to help alleviate symptoms such as nasal congestion, cough due to minor throat and bronchial irritation, headache, minor aches and pains, fever, and sore throat. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Vicks® DayQuil® Cold & Flu LiquiCaps®.

Uses

If you're dealing with the discomfort of a common cold or the flu, this medication can help provide temporary relief from several bothersome symptoms. You can expect it to ease nasal congestion, soothe a cough caused by minor throat and bronchial irritation, and alleviate headaches. Additionally, it can help reduce minor aches and pains, lower fever, and relieve a sore throat.

This medication is designed to help you feel more comfortable while your body fights off the illness, allowing you to get back to your daily activities more quickly.

Dosage and Administration

It's important to take this medication exactly as directed. For adults and children aged 12 years and older, you should take 2 softgels with a full glass of water every 4 hours. However, make sure not to exceed 4 doses in a 24-hour period to avoid any potential risks.

If you have children between the ages of 4 and 12, it's best to consult a doctor before giving them this medication. For children under 4 years old, you should not use this medication at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with it, you should take immediate action in the event of an overdose. If you suspect an overdose, seek medical help or contact a Poison Control Center at 1-800-222-122 right away. Quick medical attention is crucial, both for adults and children, even if there are no noticeable signs or symptoms. Your safety is the top priority, so please act promptly if needed.

Side Effects

Taking this product can lead to some serious side effects, so it's important to be aware of them. You should avoid using it if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate. Additionally, if you drink three or more alcoholic beverages daily, or if you are taking any other medications that contain acetaminophen, you could be at risk for severe liver damage.

Be cautious of potential allergic reactions, which may include severe skin issues like redness, blisters, or rashes. If you experience any of these symptoms, stop using the product 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 a doctor right away. Always follow the recommended dosage and consult a healthcare professional if you have any concerns or if new symptoms arise.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if you take more than 4 doses in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also lead to serious skin reactions, such as redness, blisters, or rash. If you experience any skin reactions, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, do not take it with any other medications containing acetaminophen, and avoid it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or have had an allergic reaction to it in the past. If you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or other specific health issues, ask your doctor before use. Additionally, if you are taking the blood thinner warfarin, consult your doctor or pharmacist first. Always follow the dosage instructions carefully.

You should stop taking this product and call your doctor if you feel nervous, dizzy, or sleepless, if your pain or cough worsens or lasts more than 7 days, if your fever lasts more than 3 days, or if you notice any new symptoms. In case of an overdose, seek emergency medical help or contact a Poison Control Center (1-800-222-122) immediately, as quick attention is crucial.

Overdose

Taking too much of this product, which contains acetaminophen, can lead to serious liver damage. You should be cautious not to exceed 4 doses in a 24-hour period, as this is the maximum daily amount. Additionally, avoid using other medications that also contain acetaminophen, and limit your alcohol intake to less than 3 drinks per day while using this product.

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 of the medication. Always prioritize your health and safety by consulting a healthcare professional if you have any concerns.

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 the age guidelines. For children aged 4 to under 12 years, you should consult with a doctor before using it. This ensures that the medication is appropriate and safe for your child's specific needs.

For children under 4 years old, it is advised not to use this medication at all. Always prioritize your child's safety by following these recommendations and seeking professional advice when necessary.

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 medications with a healthcare provider, who can help assess individual health needs and potential risks.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider may still consider factors like overall health, kidney function (how well your kidneys work), and any other medications being taken. Always ensure that you communicate openly with your doctor about your health history and any concerns you may have.

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 products that contain acetaminophen. Taking more than 4 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount for this medication. Additionally, avoid using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product, as this can further increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using medications.

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 products 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 certain emotional conditions—or have taken one in the past 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 room temperature. It's important to check the packaging before use: do not use the product if the printed seal under the cap is missing or damaged, as this could compromise safety and effectiveness. Always handle the product with care to maintain its integrity and ensure your safety.

Additional Information

No further information is available.

FAQ

What symptoms does this product temporarily relieve?

This product temporarily relieves common cold and flu symptoms, including nasal congestion, cough due to minor throat and bronchial irritation, headache, minor aches and pains, fever, and sore throat.

What are the active ingredients in this product?

The active ingredients include Acetaminophen, Phenylephrine HCl, and Dextromethorphan HBr.

How should adults and children 12 years and over take this product?

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 4 doses in 24 hours.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-122) right away.

Are there any warnings associated with this product?

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

What should I do if I experience a severe skin reaction?

If you experience symptoms like skin reddening, blisters, or rash, stop use and seek medical help right away.

Can I use this product if I am pregnant or breastfeeding?

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

What should I do if my sore throat is severe or persists?

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.

Is there any specific information for children under 4 years?

Children under 4 years should not use this product.

What should I do if I have liver disease?

You should ask a doctor before using this product if you have liver disease.

Packaging Info

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Daytime Cold and Flu Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by NDC 37835-520-24 and contains a formulation that includes acetaminophen, phenylephrine HCl, and dextromethorphan HBr. It is designed for daytime cold and flu relief and is presented in a dosage form of 24 SoftGels. This product is comparable to the active ingredients found in Vicks® DayQuil® Cold & Flu LiquiCaps®; however, it is not manufactured or distributed by the owner of the registered trademark.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, headache, minor aches and pains, fever, and sore throat.

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

Dosage and Administration

Patients should take the medication only as directed. The maximum allowable dosage is 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not recommended for use in children under 4 years of age.

Contraindications

There are no contraindications listed for this product. However, in the event of an overdose, it is imperative to seek immediate medical assistance 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 are apparent.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they exceed 4 doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, 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 advised to consult a physician promptly.

Contraindications Patients should not use this product if they are currently taking any other drug containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional. This product is also contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients with a known allergy to this product or any of its ingredients should avoid its use.

Precautions Healthcare professionals should recommend that patients consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent cough associated with excessive phlegm. Patients with chronic coughs, such as those related to smoking, asthma, or emphysema, should also seek medical advice prior to use. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional before using this product.

Usage Instructions Patients must adhere strictly to the recommended dosage and should not exceed the directed amount when using this product.

Monitoring and Follow-Up Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. A return of cough or the occurrence of a rash or headache that persists should also prompt immediate medical consultation, as these may indicate a serious condition.

Emergency Situations In the event of an overdose, patients must seek emergency medical help or contact a Poison Control Center (1-800-222-122) immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients uncertain about the presence of acetaminophen in their medications should consult a doctor or pharmacist. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the past two weeks should avoid this product. Those with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals experiencing a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, or emphysema should consult a healthcare provider prior to use.

Patients taking the anticoagulant warfarin should also consult a doctor or pharmacist before using this product. It is crucial for patients to adhere strictly to the recommended dosage and to stop use and seek medical advice if they experience symptoms such as nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days, fever lasting more than three days, redness or swelling, new symptoms, or a cough that recurs with a rash or headache lasting. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

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

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 or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

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 warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Daytime Cold and Flu Relief.
Details

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is not recommended for children under 4 years of age.

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. 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 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 the safety of both the mother and the developing fetus.

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 drug 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 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 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

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

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Risk Factors for Overdosage Severe liver damage may occur under the following circumstances:

  • Administration of more than 4 doses within a 24-hour period, which exceeds the maximum recommended daily amount for this product.

  • Concurrent use with other medications that also contain acetaminophen.

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

Recommended Actions Healthcare professionals should be vigilant in assessing patients for signs of acetaminophen overdosage. Immediate medical attention is warranted if an overdose is suspected. It is advisable to monitor liver function tests and consider the administration of N-acetylcysteine as an antidote, particularly if the overdose is identified within a critical time frame post-ingestion.

Potential Symptoms Symptoms of acetaminophen overdosage may not be immediately apparent and can include nausea, vomiting, loss of appetite, confusion, and jaundice. Early recognition and intervention are essential to mitigate the risk of severe hepatic injury.

In summary, awareness of the risks associated with acetaminophen overdosage and prompt management are crucial in preventing serious health consequences.

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 the following adverse reactions: severe skin reactions, which may include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-122 without delay. It is crucial to emphasize that prompt medical attention is essential for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature to maintain its integrity and effectiveness. Healthcare professionals are advised to inspect the product prior to use; specifically, it should not be used if the printed seal under the cap is missing or damaged, as this may compromise the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu Relief, 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 Daytime Cold and Flu Relief, 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.