Symptom checker
Select audience type

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

ADD CONDITION

items per page

Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate

Last content change checked dailysee data sync status

Active ingredients
  • Doxylamine Succinate 0.0125 g/237 mL – 6.25 mg
  • Acetaminophen 0.65 g/237 mL – 325 mg
  • Dextromethorphan Hydrobromide 0.03 g/237 mL – 15 mg
Reference brand
Cold and Flu
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Liquid
  • Solution
  • Syrup
  • Tablet, Chewable
  • Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
March 20, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Doxylamine Succinate 0.0125 g/237 mL – 6.25 mg
  • Acetaminophen 0.65 g/237 mL – 325 mg
  • Dextromethorphan Hydrobromide 0.03 g/237 mL – 15 mg
Reference brand
Cold and Flu
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Liquid
  • Solution
  • Syrup
  • Tablet, Chewable
  • Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
March 20, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (227)
Product Labels (227)

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

Night Time Cold and Flu is a medication designed to temporarily relieve common cold and flu symptoms, making it easier for you to rest at night. It contains three active ingredients: acetaminophen, which acts as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant that helps alleviate coughing due to minor throat and bronchial irritation; and doxylamine succinate, an antihistamine that can help reduce sneezing and runny nose.

This product is suitable for adults and children aged 12 years and older, and it is available in various forms, including liquid and softgels. It is particularly effective for relieving symptoms such as sore throat, headache, minor aches and pains, fever, runny nose, and sneezing. Additionally, it contains alcohol, which may enhance its sedative effects, helping you to sleep better while dealing with cold or flu symptoms.

Uses

You can use this medication to temporarily relieve common cold and flu symptoms, including minor aches and pains, headaches, sore throats, fevers, runny noses, sneezing, and coughs due to minor throat and bronchial irritation. It is designed to help you feel more comfortable when you're feeling under the weather, allowing you to rest and recover.

This medication does not have any known teratogenic effects (which means it is not expected to cause birth defects) and does not have any nonteratogenic effects mentioned. Always follow the dosage instructions and consult with a healthcare professional if you have any concerns or questions about using this product.

Dosage and Administration

You should take the medication only as directed and never exceed 4 doses in a 24-hour period. For adults and children aged 12 years and older, the recommended dosage is 30 mL (2 tablespoons) every 6 hours if using a liquid form, or 2 softgels with water every 6 hours if using capsules. Always measure the liquid using the dosing cup provided; do not use any other device.

Children under 12 years should not use this medication without consulting a doctor. If you are considering using other daytime or nighttime products, be sure to read each label carefully to ensure you are following the correct dosing instructions. If you have any questions or concerns, consult your healthcare provider.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) (a type of medication for depression, psychiatric conditions, or Parkinson's disease) or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist. Additionally, do not use this product in conjunction with any other medications containing acetaminophen (a common pain reliever). If you are uncertain whether a medication contains acetaminophen, seek advice from a healthcare professional.

Furthermore, do not use this product to induce sleep in children, and be cautious about exceeding the recommended dosage. It is also advisable to avoid alcoholic beverages while using this product, as they may increase drowsiness. If you have ever had an allergic reaction to this product or any of its ingredients, do not use it. Always keep medications out of reach of children and seek immediate medical help in case of overdose.

Side Effects

  • You should be aware that this product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it.

  • There is an allergy alert as acetaminophen may lead to serious skin reactions, including skin reddening, blisters, and rash. 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • While using this product, you may experience excitability, especially in children, and marked drowsiness. Avoid alcohol, and be cautious when driving or operating machinery, as alcohol, sedatives, and tranquilizers can increase drowsiness.

  • Stop using the product and consult a doctor if your pain or cough worsens or lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. These could indicate a serious condition.

  • In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical for both adults and children, even if no symptoms are present.

Warnings and Precautions

  • This product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it.

  • Allergy alert: Acetaminophen may lead to serious skin reactions, including skin reddening, blisters, and rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

  • Sore throat warning: If your sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Stop using and call your doctor if:

    • Pain or cough worsens or lasts more than 7 days.

    • Fever worsens or lasts more than 3 days.

    • Redness or swelling occurs.

    • New symptoms develop.

    • Cough returns or occurs with a rash or headache that lasts. These could indicate a serious condition.

  • In case of overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is crucial for both adults and children, even if no symptoms are noticed.

  • General precautions: Consult a doctor before use if you have liver disease, glaucoma, breathing problems, or if you are taking sedatives, tranquilizers, or blood thinners like warfarin.

Overdose

Taking more than the recommended dose of nighttime cold and flu medications can lead to serious health issues, particularly liver damage. This risk is especially high if you consume more than 4,000 mg of acetaminophen in 24 hours, take multiple medications containing acetaminophen, or drink three or more alcoholic beverages daily while using these products.

If you suspect an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no symptoms are apparent. Signs of overdose may not always be obvious, so it's better to be safe and get help right away.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any nighttime cold and flu medications. This precaution applies to all forms, including liquids, capsules, and solutions. The ingredients in these products may affect you and your baby, so seeking guidance from a healthcare provider ensures you make safe choices during this time. Always prioritize your health and the health of your child by discussing any medications with your doctor.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any nighttime cold and flu relief products. This advice applies to various forms, including liquids, capsules, and chewable tablets. The safety of these medications during lactation is not fully established, and a healthcare provider can help you weigh the benefits and risks based on your specific situation. Always prioritize your health and your baby's well-being when considering medication.

Pediatric Use

When considering nighttime cold and flu medications for children, it's important to follow specific guidelines. Children under 4 years old should not use these products at all. For children aged 4 to under 12 years, you should consult a doctor before use. Children 12 years and older can take the adult dosage, which is typically 30 mL every 6 hours for liquids or 2 softgels every 6 hours for capsules, without exceeding 4 doses in 24 hours.

Be aware that excitability may occur, especially in children, and marked drowsiness can also happen. In case of an overdose, quick medical attention is critical for both adults and children, even if no symptoms are immediately noticeable. Always keep these medications out of reach of children.

Geriatric Use

When considering nighttime cold and flu relief medications, it's important to be aware that specific dosage adjustments or safety concerns for elderly patients are often not detailed in the product inserts. However, some general considerations apply. Elderly individuals may be more sensitive to side effects, particularly from antihistamines, which can cause significant drowsiness. Additionally, products containing acetaminophen can pose risks of liver damage if taken in excess, a concern for those with reduced liver function.

It is strongly advised that you consult a healthcare professional before using these medications, especially if you have underlying health conditions such as liver disease, glaucoma, or urinary issues related to an enlarged prostate. Always follow the recommended dosages and be cautious of potential interactions with other medications you may be taking.

Renal Impairment

When considering nighttime cold and flu medications, it's important to note that most products do not provide specific information regarding dosage adjustments or safety considerations for individuals with kidney problems. However, if you have difficulty urinating due to an enlarged prostate gland, it is advisable to consult a doctor before using these medications. This precaution is particularly emphasized for several brands, including those labeled as "Nighttime Cold and Flu" and "Cold and Flu Relief."

In summary, while many nighttime cold and flu products lack detailed renal impairment guidance, seeking medical advice is crucial if you experience urinary issues or are taking other medications, such as blood thinners. Always prioritize your health by discussing any concerns with a healthcare professional.

Hepatic Impairment

You should be aware that many nighttime cold and flu products contain acetaminophen, which can lead to severe liver damage if not used properly. To avoid this risk, do not exceed 4,000 mg of acetaminophen in a 24-hour period, and be cautious if you are taking other medications that also contain acetaminophen. Additionally, consuming three or more alcoholic drinks daily while using these products can increase the risk of liver damage.

If you have liver disease, it is essential to consult a doctor before using any of these products. Always follow the recommended dosage instructions, and in case of an overdose, seek immediate medical help or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you do not notice any symptoms.

Drug Interactions

When using nighttime cold and flu medications, it's crucial to be aware of potential interactions with other drugs. If you're taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, avoid these products or wait at least two weeks after stopping the MAOI. Additionally, combining these medications with other products containing acetaminophen can increase the risk of severe liver damage, especially if you consume three or more alcoholic drinks daily. If you're on blood thinners like warfarin, be cautious, as acetaminophen can increase bleeding risk, and your INR levels may need close monitoring.

Always consult with your doctor or pharmacist before starting any new medication, especially if you're taking sedatives, tranquilizers, or other medications. This is important to ensure your safety and to avoid any serious side effects.

Storage and Handling

To ensure the effectiveness of your nighttime cold and flu relief products, store them at room temperature between 20-25°C (68-77°F). Some products may allow for storage between 15-30°C (59-86°F), but avoid exposing them to excessive heat or humidity. It's important not to refrigerate these items, as this can affect their quality. Always keep the containers tightly closed and protect them from light.

After opening, be sure to discard any unused product as directed. If you notice that the safety seal is broken or missing, do not use the product. Keep all medications out of reach of children to ensure safety.

Uses and Indications

This drug is indicated for the temporary relief of 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

Additionally, it may help relieve cough to assist with sleep.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned.

Dosage and Administration

Adults and children 12 years and older are recommended to take 30 mL (2 tablespoons) of the liquid formulation or 2 softgels with water every 6 hours, not to exceed 4 doses in a 24-hour period. For the capsule or liquid-filled forms, it is essential to swallow the softgels whole; they should not be crushed, chewed, or dissolved.

Children aged 4 to under 12 years should consult a doctor before use, while children under 4 years of age should not use this product.

When using other daytime or nighttime products, it is crucial to read each label carefully to ensure correct dosing and avoid exceeding the maximum recommended doses. The dosing cup provided with the product must be used for measuring liquid doses, and it should be kept with the product at all times.

In cases where both daytime and nighttime formulations are being used, the total combined doses should not exceed 4 doses in any 24-hour period.

For liquid formulations, it is advised to shake well before use.

Contraindications

Do not use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If there is uncertainty regarding whether a prescription drug contains an MAOI, consultation with a doctor or pharmacist is advised.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If there is uncertainty regarding whether a drug contains acetaminophen, consultation with a doctor or pharmacist is recommended.

Do not use if there has been a previous allergic reaction to this product or any of its ingredients.

Do not use to make a child sleepy.

Avoid using more than directed and refrain from consuming alcoholic drinks, as they may increase drowsiness.

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if the user takes:

  • More than 4,000 mg of acetaminophen in 24 hours.

  • With other drugs containing acetaminophen.

  • 3 or more alcoholic drinks every day while using this product.

Allergy Alert Acetaminophen may cause severe skin reactions. Symptoms may include:

  • Skin reddening

  • Blisters

  • Rash If a skin reaction occurs, stop use and seek medical help right away.

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

General Precautions Ask a doctor before use if the user has:

  • Liver disease

  • Glaucoma

  • Cough that occurs with too much phlegm (mucus)

  • A breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if the user is:

  • Taking sedatives or tranquilizers

  • Taking the blood-thinning drug warfarin

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If unsure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • If currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If unsure whether a prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if no signs or symptoms are noticed.

Stop Taking and Call Your Doctor If

  • Pain or cough gets worse or lasts more than 7 days.

  • Fever gets worse or lasts more than 3 days.

  • Redness or swelling is present.

  • New symptoms occur.

  • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Side Effects

Severe liver damage may occur if patients take more than 4,000 mg of acetaminophen in 24 hours, use other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, with symptoms including skin reddening, blisters, and rash. If a skin reaction occurs, patients should stop use and seek medical help immediately.

Additional Warnings

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

Common Adverse Reactions

  • Excitability may occur, especially in children.

  • Marked drowsiness may occur; patients are advised to avoid alcoholic drinks and be cautious when driving or operating machinery, as alcohol, sedatives, and tranquilizers may increase drowsiness.

When to Stop Use and Consult a Doctor

Patients should stop use and consult a doctor if:

  • Pain or cough worsens or lasts more than 7 days.

  • Fever worsens or lasts more than 3 days.

  • Redness or swelling is present.

  • New symptoms occur.

  • Cough returns or occurs with rash or headache that lasts, as these could be signs of a serious condition.

Overdose Warning

Taking more than the recommended dose may cause serious health problems, including liver damage. In case of overdose, patients should seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Drug Interactions

Taking certain medications for cold and flu relief can lead to significant drug interactions, particularly involving acetaminophen, dextromethorphan, doxylamine, and warfarin.

Acetaminophen Interactions

Acetaminophen is commonly found in many cold and flu medications. It may increase the risk of severe liver damage when taken with other products containing acetaminophen or when consumed with three or more alcoholic drinks daily. Additionally, acetaminophen can interact with warfarin, a blood thinner, potentially increasing the risk of bleeding; therefore, monitoring of INR levels is advised when these drugs are used together.

Dextromethorphan Interactions

Dextromethorphan may cause increased drowsiness when taken with alcohol, sedatives, or tranquilizers. It is also contraindicated for use with monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping an MAOI, as this combination can lead to serious side effects.

Doxylamine Interactions

Doxylamine, an antihistamine often included in nighttime formulations, may enhance the sedative effects of alcohol, sedatives, and tranquilizers, increasing the risk of drowsiness and respiratory depression. Caution is advised when using these products together.

General Recommendations

Patients are advised to consult a doctor or pharmacist before using these medications if they are currently taking sedatives, tranquilizers, or blood thinners like warfarin. It is also recommended to avoid using multiple products containing acetaminophen simultaneously to prevent the risk of liver damage.

Pediatric Use

Pediatric patients under 12 years of age should not use these products. For children aged 4 to under 12 years, it is advised to consult a doctor before use.

Dosage Information

  • Children 6 to under 12 years:

    • 15 mL every 4 hours, not to exceed 5 doses (10 chewable tablets) in any 24-hour period for specific formulations.

  • Children 4 to under 6 years:

    • Consult a doctor before use.

  • Children under 4 years:

    • Do not use.

Efficacy and Safety

  • Excitability may occur, especially in children.

  • Marked drowsiness may also occur.

  • In case of overdose, quick medical attention is critical for both adults and children, even if no signs or symptoms are noticed.

Special Precautions

  • These products should be kept out of reach of children.

  • Consult a doctor if symptoms persist or worsen, or if severe sore throat is present, accompanied by fever, headache, rash, nausea, or vomiting.

Geriatric Use

Geriatric patients may not have specific dosage adjustments or safety concerns outlined for the various nighttime cold and flu relief products. However, it is important to note that elderly patients may exhibit increased sensitivity to the side effects of certain ingredients, such as antihistamines, which can lead to marked drowsiness.

General considerations indicate that products containing acetaminophen may pose risks of severe liver damage if taken in excess, a concern particularly relevant for elderly patients who may have reduced liver function. Therefore, it is advisable for elderly patients to consult a healthcare professional before use, especially if they have underlying health conditions such as liver disease, glaucoma, or urinary issues related to an enlarged prostate.

While no specific age cutoffs or detailed geriatric-specific information are provided in the inserts, caution is warranted when administering these products to elderly patients, particularly those with potential reduced kidney function or other comorbidities. Regular monitoring and consultation with a healthcare provider are recommended to ensure safe and effective use.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the listed nighttime cold and flu medications, as safety during pregnancy has not been established. The available data indicates that the use of these products during pregnancy may pose risks, and potential fetal impacts are not well characterized.

All formulations, including liquids, capsules, and solutions, carry the recommendation to seek professional advice prior to use if the patient is pregnant or breastfeeding. This precaution is essential to ensure the safety of both the mother and the developing fetus.

Healthcare providers are advised to evaluate the risks and benefits of treatment options for pregnant patients experiencing cold and flu symptoms, considering the lack of comprehensive safety data for these medications in this population.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any nighttime cold and flu relief products, regardless of the formulation (liquid, capsule, or solution). This recommendation applies to a wide range of products, including those containing common ingredients such as acetaminophen, dextromethorphan, and doxylamine succinate.

There is no specific data provided regarding the excretion of these medications in breast milk or their potential effects on breastfed infants. However, the general guidance emphasizes the importance of professional consultation to ensure the safety of both the mother and the infant during breastfeeding. Given the variability in individual responses and the potential for adverse effects, healthcare providers can offer tailored advice based on the specific product and the mother's health status.

Renal Impairment

Patients with renal impairment should be aware that the majority of the reviewed products do not provide specific information regarding dosage adjustments, monitoring, or safety considerations related to reduced kidney function.

For those experiencing difficulty urinating, particularly due to an enlarged prostate gland, it is advised to consult a healthcare professional before using any of these medications. This precaution is noted across several labels, indicating a potential interaction or exacerbation of symptoms related to urinary function.

Overall, the lack of detailed guidance on renal impairment across these products suggests that healthcare providers should exercise caution and consider individual patient circumstances when recommending these medications to patients with compromised kidney function. Regular monitoring and consultation with a healthcare provider are recommended to ensure safe and effective use.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. Severe liver damage may occur if the following conditions are met:

  • More than 4,000 mg of acetaminophen is taken in a 24-hour period.

  • Acetaminophen is taken in conjunction with other medications containing acetaminophen.

  • Three or more alcoholic drinks are consumed daily while using these products.

It is advised that patients with liver disease consult a healthcare professional before using any acetaminophen-containing product. Monitoring for signs of liver damage is essential, especially in cases of overdose, which may necessitate immediate medical attention. In the event of an overdose, patients should seek help from a medical professional or contact a Poison Control Center immediately.

When using these products, it is recommended to avoid alcoholic beverages to minimize the risk of liver damage.

Overdosage

Taking more than the recommended dose of these nighttime cold and flu medications may lead to serious health problems, including liver damage. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially observed.

Symptoms of overdose may include severe liver damage, which can occur if more than 4,000 mg of acetaminophen is ingested within a 24-hour period, or if the product is taken in conjunction with other medications containing acetaminophen. Additionally, consuming three or more alcoholic drinks daily while using these products may increase the risk of liver damage.

Prompt intervention is critical, and healthcare professionals should be contacted without delay in cases of suspected overdose. Monitoring for symptoms and providing immediate care can significantly impact outcomes.

Nonclinical Toxicology

Teratogenic Effects

Several products indicate that if a patient is pregnant or breastfeeding, it is advisable to consult a health professional before use. However, no specific teratogenic effects have been documented in the available data.

Non-Teratogenic Effects

Non-teratogenic effects reported across various products include potential excitability, particularly in children, and marked drowsiness. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. No specific non-teratogenic effects were mentioned for many products.

Nonclinical Toxicology

The available data does not provide specific details regarding nonclinical toxicology for the majority of the products reviewed.

Animal Pharmacology and Toxicology

No relevant information regarding animal pharmacology and toxicology has been provided in the reviewed product labels.

Storage and Handling

Products are supplied in various forms including liquid, capsule, and liquid-filled configurations. The recommended storage conditions for these products generally range from 20-25°C (68-77°F), with some allowances for excursions between 15-30°C (59-86°F). It is important to avoid refrigeration and excessive heat, as these conditions can compromise the integrity of the products.

Storage Conditions

  • Liquid Forms: Store between 20-25°C (68-77°F). Do not refrigerate. Protect from light and keep containers tightly closed. Discard after opening.

  • Capsule and Liquid-Filled Forms: Store at room temperature, typically between 15-30°C (59-86°F). Avoid excessive heat and high humidity. Ensure that the packaging is intact and tamper-evident seals are not broken.

Handling Requirements

  • Keep out of reach of children.

  • Discard any product that shows signs of tampering or if the seal is broken.

  • For products that specify protection from light, ensure they are stored in a suitable container that provides this protection.

These guidelines are essential for maintaining the efficacy and safety of the products throughout their shelf life.

Product Labels

The table below lists all over-the-counter labels containing acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 227 FDA Structured Product Labels (DailyMed) for Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate (marketed as Night Time Cold and Flu, Nighttime Cold and Flu Relief, Nighttime Cold/Flu Relief), with data retrieved by a validated AI data-extraction workflow. This includes 227 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. 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.