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Cold and Flu

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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 2019
Label revision date
November 13, 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 2019
Label revision date
November 13, 2025
Manufacturer
Safeway, Inc.
Registration number
M012
NDC root
21130-598
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 product is designed to temporarily relieve common cold and flu symptoms, helping you feel more comfortable when you're under the weather. It contains three active ingredients: acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant). Together, these ingredients work to alleviate aches, fever, sore throat, cough, nasal congestion, and sinus pressure.

Additionally, this medication is alcohol-free and antihistamine-free, making it a suitable option for many people seeking relief from cold and flu symptoms. It comes in softgel form, which are liquid-filled capsules that are easy to swallow.

Uses

If you're dealing with the discomfort of a common cold or the flu, this medication can help provide temporary relief from a variety of symptoms. You can expect it to ease minor aches and pains, headaches, sore throats, nasal congestion, fever, sinus pressure, and cough caused by minor irritation in your throat and bronchial area.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus. It's designed to help you feel better while you recover from your illness.

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 softgels with a full glass of water every 4 hours. Make sure to swallow the softgels whole; do not crush, chew, or dissolve them. Remember, you should not take more than 4 doses within a 24-hour period, and you should never exceed the recommended amount.

If you are considering using other Daytime or Nighttime products, be sure to read each label thoroughly to avoid taking too much. Also, keep in mind that this medication is not suitable for children under 12 years old. Always adhere to these guidelines to prevent any potential overdose.

What to Avoid

You should avoid using this medication if you are currently taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this medication 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. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

It's also important to follow the recommended dosage and not exceed it, as doing so can lead to serious health risks. Always prioritize your safety by discussing any concerns or questions with your healthcare provider.

Side Effects

You should be aware that 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. Additionally, acetaminophen may cause serious skin reactions, including skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

It's important to consult a doctor if your pain, cough, or nasal congestion worsens or lasts more than seven days, or if you experience nervousness, dizziness, sleeplessness, or a fever that persists for more than three days. Be alert for any new symptoms or if your cough returns with a rash or headache, as these could indicate a more serious condition. In case of an overdose, which can cause serious liver damage, seek medical assistance or contact a Poison Control Center right away, even if you don't notice any symptoms.

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 reddening, 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor right away. It's important to get medical attention if you suspect an overdose, as this can cause serious liver damage. Contact a Poison Control Center (1-800-222-1222) or seek medical help immediately, even if you don't notice any symptoms.

You should stop using this product and call your doctor if your pain, cough, or nasal congestion worsens or lasts more than seven days, if you experience nervousness, dizziness, or sleeplessness, if your fever worsens or lasts more than three days, or if you notice redness or swelling. New symptoms or a returning cough with a rash or headache that lasts could indicate a serious condition, so it's best to consult your healthcare provider.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial, not only for adults but also for children, even if you don’t see any signs or symptoms of an overdose.

Remember, acting fast can make a significant difference in the outcome, so don’t hesitate to reach out for help if you think an overdose has occurred.

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 softgels taken with water every 4 hours, but be sure not to exceed 4 doses in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to 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 with your doctor 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always discuss your full list of medications, including over-the-counter drugs and supplements, as well as any lab tests you may need. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C and 30°C (59°F - 86°F). It's important to avoid exposing it to excessive heat, as this can affect its effectiveness and safety.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. By following these guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What symptoms does this product relieve?

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

What are the active ingredients in this product?

The active ingredients include acetaminophen (325 mg) as a pain reliever and fever reducer, dextromethorphan HBr (10 mg) as a cough suppressant, and phenylephrine HCl (5 mg) as a nasal decongestant.

How should I 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. Swallow the softgels whole; do not crush, chew, or dissolve.

Are there any warnings I should be aware of?

Yes, do not exceed the recommended dosage as it can cause serious liver damage. If you experience severe skin reactions, sore throat that persists, or if symptoms worsen, consult a doctor.

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

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children.

Who should not use this product?

Do not use this product if you are under 12 years old, taking other drugs containing acetaminophen, or currently using a prescription monoamine oxidase inhibitor (MAOI).

How should I store this product?

Store the product between 15°C and 30°C (59°F - 86°F) and avoid excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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 symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, headache, sore throat, nasal congestion, fever, sinus pressure, and cough due to minor throat and bronchial irritation.

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 four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications containing acetaminophen or consume three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions 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, particularly if it 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.

Healthcare professionals must emphasize the importance of adhering to the recommended dosage, as exceeding this can lead to serious liver damage. In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center (1-800-222-1222) promptly, even if no symptoms are apparent, as rapid intervention is essential for both adults and children.

Patients should be instructed to stop using the product and consult a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; nervousness, dizziness, or sleeplessness; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. 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. In cases of overdose, immediate medical attention is critical, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

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

In addition, patients experiencing a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a healthcare professional immediately.

Patients are advised to stop use and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or lasts more than seven days; nervousness, dizziness, or sleeplessness develops; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms arise; or if a cough returns or occurs with a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may 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, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate 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

Taking more than the recommended dose of this medication can lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Early intervention can significantly impact the outcome and mitigate potential complications associated with liver damage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

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

Patients should be advised to discontinue use and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should seek medical advice if they experience nervousness, dizziness, or sleeplessness. If a fever worsens or lasts more than three days, or if any redness or swelling occurs, patients should also stop use and contact their healthcare provider. New symptoms or a cough that returns or occurs with a rash or headache that lasts should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 15°C to 30°C (59°F to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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

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.