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Dextromethorphan hydrobromide/Doxylamine succinate

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Active ingredients
  • Doxylamine Succinate 12.5 mg/30 mL – 6.25 mg
  • Dextromethorphan Hydrobromide 20 mg/20 mL – 15 mg
Reference brand
Night-Time
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Chewable Gel
  • Liquid
  • Solution
  • Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
March 11, 2026
Active ingredients
  • Doxylamine Succinate 12.5 mg/30 mL – 6.25 mg
  • Dextromethorphan Hydrobromide 20 mg/20 mL – 15 mg
Reference brand
Night-Time
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage forms
  • Chewable Gel
  • Liquid
  • Solution
  • Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
March 11, 2026

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Drug Overview

Robitussin Honey Maximum Strength Nighttime Cough DM is a cough syrup designed to provide relief from coughs caused by minor throat and bronchial irritation, often associated with colds. It contains two active ingredients: Dextromethorphan HBr, which acts as a cough suppressant to help control your urge to cough, and Doxylamine Succinate, an antihistamine that helps alleviate symptoms of allergies such as runny nose, sneezing, and itchy, watery eyes. This formulation is intended for adults and children aged 12 and older, and it is available in a liquid form.

This product is particularly useful for nighttime use, as it helps you sleep by reducing coughing and other allergy-related symptoms. It is available in a pleasant honey flavor, making it easier to take, especially for those who may be sensitive to the taste of medications.

Uses

You can use this medication to temporarily relieve cough caused by minor throat and bronchial irritation, which often occurs with a cold. It also helps alleviate symptoms associated with hay fever or other upper respiratory allergies, such as runny nose, sneezing, itchy or watery eyes, and itching of the nose or throat.

Additionally, this medication is designed to control your urge to cough, making it easier for you to sleep at night.

Dosage and Administration

You should measure your dose using the dosing cup provided with the product. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours, or 30 mL every 6 hours depending on the specific product. Do not exceed 4 doses in any 24-hour period.

If you are giving the medication to children aged 6 to under 12 years, the dosage is typically 10 mL every 6 hours for some products, or 1 chewable tablet every 4 hours for chewable forms, not exceeding 6 chewable tablets in a 24-hour period. Children under 6 years should not use these products. Always follow the specific instructions on the label and consult a doctor if you have any questions.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, consult your doctor or pharmacist. Additionally, do not use this product to sedate a child or make them sleepy, and always adhere to the recommended dosage.

It's important to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can increase drowsiness. Exercise caution when driving or operating machinery, as drowsiness may impair your ability to do so safely. If your cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice.

Side Effects

You may experience several side effects when using nighttime cough medications. Common reactions include marked drowsiness and excitability, particularly in children. It's important to avoid alcoholic drinks, as they can increase drowsiness, and to be cautious when driving or operating machinery.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the product and consult a doctor, as these could indicate a serious condition. Additionally, consult a healthcare professional if you have glaucoma, difficulty urinating due to an enlarged prostate, or a chronic cough associated with excessive mucus or respiratory conditions like asthma or emphysema. Avoid using these medications if you are currently taking a monoamine oxidase inhibitor (MAOI) or have recently stopped one.

Warnings and Precautions

  • Do not use these cough medications to sedate a child or make them sleepy.

  • Avoid using if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or if you have stopped taking an MAOI within the last two weeks. If unsure, consult your doctor or pharmacist.

Before using, consult a doctor if you have:

  • Glaucoma (a condition that affects your eyes)

  • Trouble urinating due to an enlarged prostate gland

  • A cough with excessive phlegm (mucus)

  • Breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema

If you are taking sedatives or tranquilizers, ask your doctor or pharmacist before use.

While using these products:

  • Do not exceed the recommended dosage.

  • Marked drowsiness may occur, and excitability may happen, especially in children.

  • Avoid alcohol, as it can increase drowsiness.

  • Use caution when driving or operating machinery.

Stop use and call your doctor if:

  • Your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could indicate a serious condition.

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

Overdose

If you suspect an overdose of any cough medication, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may include excessive drowsiness, excitability (especially in children), or other unusual symptoms.

To prevent overdose, always follow the recommended dosage on the label. Be cautious when using these medications alongside alcohol, sedatives, or tranquilizers, as they can increase drowsiness and impair your ability to drive or operate machinery safely. If you experience any concerning symptoms after taking a cough medication, do not hesitate to reach out for help.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any cough medications. This includes various forms such as solutions, chewable gels, and syrups. The safety of these products during pregnancy and breastfeeding has not been fully established, so seeking professional advice is crucial to ensure the well-being of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications. This includes various cough syrups and solutions, as ingredients may pass into breast milk and potentially affect your infant. Always prioritize your health and your baby's safety by seeking guidance from a qualified expert.

Pediatric Use

You should be aware that many nighttime cough and cold products are not suitable for children under 12 years of age. Specifically, products like Tussin DM Nighttime Max, Robitussin Nighttime Cough DM Soft Chews, and others clearly state that they should not be used in this age group. For children aged 6 to under 12 years, some products allow use but require specific dosages, such as 10 mL every 6 hours for certain syrups, while chewable gels can be given at a rate of 1 every 4 hours, not exceeding 6 in 24 hours.

It's important to note that excitability and marked drowsiness may occur, especially in children. Always keep these products out of reach of children, and in case of overdose, seek medical help or contact a Poison Control Center immediately. If your child is under 4 years old, do not use these products without consulting a doctor.

Geriatric Use

When considering nighttime cough medications, it's important to be aware of certain precautions, especially for older adults. Many products, such as Robitussin Nighttime Cough DM Soft Chews and Honeyworks Plus Adult Nighttime Cough Syrup, may cause marked drowsiness. Therefore, you should avoid alcohol and be cautious when driving or operating machinery, as these substances can increase drowsiness.

If you have specific health concerns, such as difficulty urinating due to an enlarged prostate, glaucoma, or chronic respiratory issues (like asthma or chronic bronchitis), consult your doctor before using these medications. Always check with a healthcare professional if you are taking other sedatives or tranquilizers, as they may interact with these cough syrups.

Renal Impairment

When using medications for cough relief, it's important to be aware of how kidney health can affect your treatment. For some products, such as Tussin DM, if you have renal impairment (reduced kidney function), you may need a lower dose. It's advisable to have your kidney function assessed, particularly your creatinine clearance, before starting therapy. Regular monitoring of your kidney function is also recommended to prevent potential toxicity, especially if you have significant kidney issues.

Unfortunately, many cough medications do not provide specific guidance on dosage adjustments or monitoring for individuals with kidney problems. Always consult your healthcare provider for personalized advice and to ensure safe use of these medications.

Hepatic Impairment

You should be aware that some cough medications may require special attention if you have liver problems. For instance, with Tussin Dm, dosage adjustments might be necessary, and it's recommended to monitor liver function tests closely. This means that if your liver is not functioning properly, your doctor may need to change how much of the medication you take or check your liver health more frequently.

For other cough medications listed, such as Robitussin and Mucinex products, there is no specific information provided regarding liver impairment, dosage adjustments, or monitoring. If you have liver issues, it's always best to consult your healthcare provider before using any medication to ensure it's safe for you.

Drug Interactions

If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, you should not use any products containing dextromethorphan or doxylamine, as this can lead to serious interactions. Additionally, be cautious when consuming alcohol, sedatives, or tranquilizers while using these medications, as they can increase drowsiness and impair your ability to perform tasks that require alertness, such as driving.

It's essential to discuss all medications and any potential interactions with your healthcare provider to ensure your safety and well-being. Always inform them about any prescription or over-the-counter drugs you are taking, as well as any recent changes in your medication regimen.

Storage and Handling

To ensure the effectiveness of your nighttime cough products, store them at room temperature between 20-25°C (68-77°F). Avoid refrigeration, as it can affect the quality of the solution or chewable forms. Always keep the products in a cool, dry place, and check the packaging for the expiration date and lot number to ensure safety.

When disposing of any unused or expired medication, follow local guidelines for medication disposal. If the product has a tamper-evident seal that is broken or missing, do not use it.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold. It also temporarily alleviates symptoms associated with hay fever or other upper respiratory allergies, including:

  • Runny nose

  • Sneezing

  • Itchy, watery eyes

  • Itching of the nose or throat

Additionally, this drug controls the impulse to cough to help facilitate sleep.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned in the provided information.

Dosage and Administration

Adults and children 12 years and older are recommended to take 20 mL to 30 mL of the solution every 6 hours, not to exceed 4 doses in any 24-hour period. The specific dosage for adults and children 12 years and older may vary slightly depending on the product, with some formulations allowing for 30 mL every 6 hours, while others specify 20 mL.

For chewable formulations, adults and children 12 years and older should take 2 chewable tablets or gels every 4 hours, not to exceed 12 chewable tablets or gels in any 24-hour period.

Children aged 6 to under 12 years may take 10 mL to 1 chewable tablet or gel every 4 hours, with a maximum of 6 chewable tablets or gels in a 24-hour period.

Children under 6 years of age should not use these products.

All dosages must be measured using the dosing cup provided with the product, and it is essential to keep the dosing cup with the product to ensure accurate measurement. It is advised to take the medication only as directed and to consult a healthcare professional if there are any questions regarding the appropriate use.

Contraindications

Do not use 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, consult a doctor or pharmacist before use.

Do not use to sedate a child or to make a child sleepy.

In addition, avoid alcoholic drinks, as alcohol, sedatives, and tranquilizers may increase drowsiness. Use caution when driving a motor vehicle or operating machinery.

Warnings and Precautions

Do not use to sedate a child or to make a child sleepy. Do not use 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, consult a doctor or pharmacist before taking this product.

General Precautions

Consult a doctor before use if the individual has:

  • Trouble urinating due to an enlarged prostate gland.

  • Glaucoma.

  • A 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.

  • A sodium-restricted diet (for children).

Additionally, consult a doctor or pharmacist before use if taking sedatives or tranquilizers.

Usage Warnings

  • Do not exceed the recommended dosage.

  • Marked drowsiness may occur; avoid alcoholic drinks.

  • Alcohol, sedatives, and tranquilizers may increase drowsiness.

  • Use caution when driving a motor vehicle or operating machinery.

  • Excitability may occur, especially in children.

Stop Taking and Call Your Doctor

Stop use and consult a doctor if:

  • Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Emergency Medical Help

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

Side Effects

Marked drowsiness and excitability may occur, particularly in children. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

Warnings:

  • Do not use to sedate a child or to make a child sleepy.

  • Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI drug. If unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist.

Serious Adverse Reactions:Patients should stop use and consult a doctor if:

  • Cough persists for more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

Pre-existing Conditions:Consult a doctor before use if the patient has:

  • Trouble urinating due to an enlarged prostate gland.

  • Glaucoma.

  • A cough that occurs with excessive phlegm (mucus).

  • A breathing problem or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Additional Considerations:

  • In case of overdose, seek medical help or contact a Poison Control Center immediately.

This information is derived from multiple product labels and reflects common adverse reactions and warnings associated with nighttime cough medications.

Drug Interactions

Dextromethorphan and doxylamine, commonly found in various nighttime cough preparations, have significant interactions with monoamine oxidase inhibitors (MAOIs). It is contraindicated to use these products if a patient is currently taking an MAOI or has stopped taking one within the last two weeks, as this may lead to serious interactions.

Pharmacokinetic Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): The use of dextromethorphan and doxylamine in conjunction with MAOIs can result in severe side effects. This contraindication applies to multiple products, including Tussin DM Nighttime Max, Robitussin Nighttime Cough DM Soft Chews, and others.

Pharmacodynamic Interactions

  • CNS Depressants: Alcohol, sedatives, and tranquilizers may enhance the sedative effects of dextromethorphan and doxylamine. Caution is advised when engaging in activities that require alertness, such as driving or operating machinery. This warning is consistent across various formulations, including Tussin DM Nighttime Max, Robitussin Maximum Strength Nighttime Cough DM, and Childrens Honeyworks Plus Nighttime Cough Syrup.

Summary of Recommendations

Patients should avoid the use of any products containing dextromethorphan or doxylamine if they are currently on MAOIs or have recently discontinued them. Additionally, the concurrent use of alcohol, sedatives, or tranquilizers should be approached with caution due to the potential for increased drowsiness and impaired alertness.

Pediatric Use

Pediatric patients under 12 years of age should not use the following products: Tussin Dm Nighttime Max, Robitussin Nighttime Cough Dm Soft Chews, Cough Dm, Robitussin Maximum Strength Nighttime Cough Dm, Amazon, Honeyworks Plus Adult Nighttime Cough Syrup, and Meijer Maximum Strength Nighttime Cough Dm.

For children aged 6 to under 12 years, the following dosing guidelines apply:

  • Childrens Honeyworks Plus Nighttime Cough Syrup: 10 mL every 6 hours.

  • Childrens Nighttime Mucus: 1 chewable gel every 4 hours, not to exceed 6 chewable gels in any 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a doctor before use of the Night-Time liquid product.

Marked drowsiness and excitability may occur, especially in children. These products should be kept out of reach of children, and in case of overdose, medical help or contact with a Poison Control Center should be sought immediately. Additionally, these products should not be used to sedate a child or to induce sleepiness.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the majority of the products reviewed.

For products such as Robitussin Nighttime Cough DM Soft Chews and Honeyworks Plus Adult Nighttime Cough Syrup, it is advised that elderly patients consult a healthcare professional before use if they have conditions such as trouble urinating due to an enlarged prostate, glaucoma, or chronic respiratory issues. Marked drowsiness may occur with these products, and it is recommended to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery due to the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Overall, while there are no specific dosage modifications or age cutoffs indicated, healthcare providers should remain vigilant in monitoring geriatric patients for any adverse effects, particularly those related to sedation and respiratory conditions.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using any of the cough and cold medications listed, including various formulations such as solutions, liquids, chewable gels, and tablets. The available data indicates that there are no specific studies detailing the risks or fetal impacts associated with these products during pregnancy. However, the general recommendation is to seek professional guidance to ensure safety for both the mother and the developing fetus.

Given the lack of detailed risk categorization or study results, healthcare providers should exercise caution and consider the individual circumstances of pregnant patients when recommending these medications.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the following products if they are pregnant or breastfeeding. This recommendation applies to various formulations, including solutions, chewable tablets, and syrups, such as Tussin DM Nighttime Max, Robitussin Nighttime Cough DM Soft Chews, and Children's Honeyworks Plus Nighttime Cough Syrup, among others.

There is no specific data provided regarding the excretion of these products in breast milk or their effects on breastfed infants. Therefore, healthcare providers should exercise caution and consider the potential risks versus benefits when recommending these medications to lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain cough medications. While many product labels do not provide specific information regarding dosage adjustments or monitoring for patients with kidney problems, one label indicates that renal impairment may necessitate a reduced dose of the medication.

It is advised that patients with renal impairment have their creatinine clearance assessed prior to initiating therapy. Regular renal function tests are recommended for those with existing kidney issues to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity.

Overall, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments when using certain medications. Specifically, for the product labeled as Tussin Dm, it is noted that dosage adjustments may be necessary for patients with liver problems. Additionally, special monitoring of liver function tests is recommended for these patients, and caution should be exercised when administering the drug to individuals with liver dysfunction.

For all other products reviewed, including Robitussin Honey Maximum Strength Nighttime Cough Dm, Mucinex Children's Mighty Chews Cough Nighttime, and various formulations of Tussin, there is no specific information provided regarding hepatic impairment, dosage adjustments, special monitoring, or precautions for patients with liver problems. Therefore, healthcare providers should consider the lack of data and exercise clinical judgment when prescribing these medications to patients with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately. The national hotline for Poison Control is 1-800-222-1222.

Symptoms of overdose may include marked drowsiness and excitability, particularly in children. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and individuals are advised to avoid alcoholic beverages. Caution should be exercised when driving or operating machinery due to the potential for increased sedation.

Monitoring for these symptoms is essential, and appropriate medical intervention should be initiated as soon as an overdose is suspected.

Nonclinical Toxicology

Teratogenic Effects

For several products, including Robitussin Nighttime Cough DM Soft Chews, Cough DM, Childrens Honeyworks Plus Nighttime Cough Syrup, Tussin DM Max, Amazon, Honeyworks Plus Adult Nighttime Cough Syrup, Meijer Maximum Strength Nighttime Cough DM, Childrens Nighttime Mucus, and Cough Relief, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. No specific teratogenic effects were reported for other products.

Non-Teratogenic Effects

Marked drowsiness has been noted as a potential effect across multiple formulations, including Tussin DM Max, Honeyworks Plus Adult Nighttime Cough Syrup, and Childrens Nighttime Mucus. Additionally, excitability may occur, particularly in children, as indicated for Cough DM, Tussin DM Max, and Cough Relief. The presence of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Nonclinical Toxicology Section

No specific nonclinical toxicology details were provided for the majority of the products reviewed. Information regarding animal pharmacology and toxicology was also not available across the various formulations.

Storage and Handling

Robitussin Honey Maximum Strength Nighttime Cough DM is supplied as a solution. It should be stored at a temperature range of 20-25°C (68-77°F).

Mucinex Children's Mighty Chews Cough Nighttime is available in chewable tablet form. It is recommended to store this product in a cool, dry place at 20-25°C (68-77°F).

Tussin DM Nighttime Max is also provided as a solution and should be stored at 20-25°C (68-77°F).

CVS Dex-Dox Kids Nighttime Cough Suppressant comes in a chewable gel form. It should be stored in a cool, dry place at 20-25°C (68-77°F).

Cough Relief is supplied as a liquid and must be stored between 20-25°C (68-77°F). It should not be refrigerated.

Robitussin Nighttime Cough DM Soft Chews are available as chewable tablets and should be stored at 20-25°C (68-77°F).

Cough DM is provided as a solution. It should be stored at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). The expiration date and lot number can be found on the end flap.

Night-Time is supplied as a liquid and should be stored at room temperature.

Children's Honeyworks Plus Nighttime Cough Syrup is available as a solution and should also be stored at room temperature.

Robitussin Maximum Strength Nighttime Cough DM is supplied as a solution and should be stored at 20-25°C (68-77°F).

Nighttime Cough is available in solution form and should be stored at 20-25°C (68-77°F).

Another formulation of Nighttime Cough is supplied as a liquid and must be stored between 20-25°C (68-77°F). It should not be refrigerated.

Tussin DM is provided as a solution and should be stored at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). The expiration date and lot number can be found on the end flap.

Tussin DM Max is also supplied as a solution and should be stored at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). The expiration date and lot number can be found on the end flap.

Children's Robitussin Honey Nighttime Cough DM is available as a solution and should be stored at 20-25°C (68-77°F).

Amazon is supplied as a solution and should be stored at room temperature.

DG Health Tussin is provided as a solution and should be stored at 20-25°C (68-77°F).

Nighttime Cough DM is available as a solution and should be stored at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). The expiration date and lot number can be found on the end flap.

Honeyworks Plus Adult Nighttime Cough Syrup is supplied as a solution and should be stored at room temperature.

Tussin Nighttime Cough is available as a solution and should be stored at 20-25°C (68-77°F).

CareOne Tussin DM is provided as a solution and should be stored at 20-25°C (68-77°F).

Night Time Cough is available in liquid form and should be stored between 20-25°C (68-77°F). It should not be refrigerated.

Meijer Maximum Strength Nighttime Cough DM is supplied as a solution and should be stored at room temperature.

Tussin DM Max is provided as a solution and should be stored at 25°C (77°F), with excursions permitted between 15-30°C (59-86°F). The expiration date and lot number can be found on the end flap.

Children's Nighttime Mucus is available as a chewable gel and should be stored between 20-25°C (68-77°F). It should not be refrigerated and is tamper evident; do not use if the printed safety seal is broken or missing.

Topcare Tussin DM Max is supplied as a solution and should be stored at 20-25°C (68-77°F).

Nighttime Cough Relief is available in liquid form and should be stored between 20-25°C (68-77°F). It should not be refrigerated.

Another formulation of Night Time Cough is supplied as a liquid and should be stored between 20-25°C (68-77°F). It should not be refrigerated.

Cough Relief is provided as a liquid and must be stored between 20-25°C (68-77°F). It should not be refrigerated.

Product Labels

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

FDA-Approved Dextromethorphan hbr, 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 30 FDA Structured Product Labels (DailyMed) for Dextromethorphan Hbr, Doxylamine Succinate (marketed as Robitussin Honey Maximum Strength Nighttime Cough Dm, Mucinex Childrens Mighty Chews Cough Nighttime, Tussin Dm Nighttime Max), with data retrieved by a validated AI data-extraction workflow. This includes 30 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.

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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.