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Nighttime Cold and Flu

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Active ingredients
  • Doxylamine Succinate 0.0125 g/237 mL
  • Acetaminophen 0.65 g/237 mL
  • Dextromethorphan Hydrobromide 0.03 g/237 mL
Other brand names
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 26, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Doxylamine Succinate 0.0125 g/237 mL
  • Acetaminophen 0.65 g/237 mL
  • Dextromethorphan Hydrobromide 0.03 g/237 mL
Other brand names
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2024
Label revision date
January 26, 2026
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-9143
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 the common cold and flu. If you're experiencing discomfort from a cough due to minor throat and bronchial irritation, a sore throat, headache, minor aches and pains, fever, or a runny nose and sneezing, this drug can help ease those symptoms.

By targeting these common issues, it aims to make you feel more comfortable while your body fights off the illness. Always remember to consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps ease a cough caused by minor throat and bronchial irritation, soothes a sore throat, and alleviates headaches. Additionally, it can help reduce minor aches and pains, lower fever, and manage a runny nose and sneezing.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with this medication. This makes it a safe option for managing your cold and flu symptoms without the worry of affecting pregnancy.

Dosage and Administration

It's important to take this medication exactly as directed. Use only the dose cup that comes with the medication to ensure you measure the correct amount. For adults and children aged 12 years and older, the recommended dose is 30 mL every 6 hours, but remember not to exceed 4 doses in a 24-hour period.

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 cautious when using this medication. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Additionally, keep this medication out of reach of children to ensure their safety.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help. Taking these precautions can help you use the medication safely and effectively.

Side Effects

Taking this medication comes with some important safety information. You should be aware that taking more than 4 doses in 24 hours can lead to severe liver damage, especially if you are also using other products containing acetaminophen or consuming 3 or more alcoholic drinks daily.

Additionally, acetaminophen can cause serious skin reactions, which may present as skin reddening, blisters, or a rash. If you notice any of these symptoms, stop using the medication and seek medical help immediately. If you experience a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it’s important to consult a doctor right away.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4 doses in 24 hours or if you consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these skin reactions, stop using the product and seek medical help immediately.

If you have a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor right away. In case of an overdose, it’s crucial to get emergency medical help or contact a Poison Control Center immediately, even if you don’t notice any symptoms. Your health and safety are important, so please take these warnings seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 have a child aged 4 to under 12 years, it's important to consult with a doctor before using this medication. They can provide guidance on whether it's appropriate for your child's specific situation. For children under 4 years old, you should not use this medication at all, as it is not safe for that age group. Always prioritize your child's health by seeking professional advice when it comes to medications.

Geriatric Use

When it comes to using this medication, there are no specific dosage adjustments or safety concerns noted for older adults. This means that, generally, you can take the same dose as younger adults without needing to change it. However, it's always important to discuss your individual health needs with your healthcare provider, especially if you have other medical conditions or are taking multiple medications. They can help ensure that this treatment is safe and effective for you.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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. This limit applies not only to this product but also to any other medications that contain acetaminophen. Additionally, if you consume 3 or more alcoholic drinks each day while using this product, your risk of liver damage increases significantly.

To protect your liver, always follow the recommended dosage and be mindful of your alcohol intake. If you have any concerns or questions about using this product, especially in relation to your liver health, please consult your healthcare provider for personalized 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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of the product.

Additional Information

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

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves common cold and flu symptoms, including cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, runny nose, and sneezing.

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

Adults and children 12 years and over should take 30 mL every 6 hours, not exceeding 4 doses in 24 hours.

What should I do if I have a sore throat that lasts more than 2 days?

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.

Are there any warnings associated with this drug?

Yes, this product contains acetaminophen, which can cause severe liver damage if you exceed 4 doses in 24 hours or consume 3 or more alcoholic drinks daily while using it. It may also cause severe skin reactions.

What should I do in case of an overdose?

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

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

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

What should I do if I experience a skin reaction?

If you experience a skin reaction such as reddening, blisters, or rash, stop use and seek medical help right away.

What precautions should I take when using this drug?

Take only as directed, use the provided dose cup, and keep it out of reach of children. Do not use if you are under 4 years old without consulting a doctor.

Packaging Info

Below are the non-prescription pack sizes of Nighttime Cold and Flu (acetaminophen, dextromethorphan, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nighttime Cold and Flu.
Details

Drug Information (PDF)

This file contains official product information for Nighttime 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 cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should take the medication only as directed and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period.

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

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

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use due to potential risks to the fetus or infant.

The product must be kept out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding 4 doses within a 24-hour period—considering all medications containing acetaminophen—or consuming 3 or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

Emergency medical help should be sought in the event of an overdose. It is crucial for both adults and children to receive prompt medical attention, even if no signs or symptoms are immediately apparent. Healthcare professionals should encourage patients to contact a Poison Control Center or seek medical help right away in such situations.

Patients must be instructed to stop taking the product and contact their doctor if any skin reactions occur or if the sore throat is severe, persists beyond 2 days, or is accompanied by any of the aforementioned symptoms.

Side Effects

Severe liver damage may occur in patients who exceed 4 doses within a 24-hour period, which is the maximum daily amount for this product. This risk is heightened when used in conjunction with other medications containing acetaminophen or when patients consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, if patients experience a sore throat that is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Nighttime Cold and Flu (acetaminophen, dextromethorphan, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nighttime Cold and Flu.
Details

Pediatric Use

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

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the provided information. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be aware of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4 doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Due to the risk of liver damage, it is essential for patients with compromised liver function to monitor their acetaminophen intake closely and consult with a healthcare professional regarding appropriate dosing and potential alternatives. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center. Healthcare providers should stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Nighttime 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 Nighttime 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.