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Goodmeds Non-Drowsy Cough Relief

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Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
December 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
December 29, 2025
Manufacturer
Cabinet Health P. B. C.
Registration number
M012
NDC root
82725-4010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You may find this medication helpful if you're experiencing a cough caused by minor irritation in your throat and bronchial tubes, which can happen with a cold. It is designed to provide temporary relief from such coughs, helping you feel more comfortable as you recover.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially during a cold, this medication can help provide temporary relief. It's designed to soothe that discomfort, making it easier for you to go about your day.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects during pregnancy) associated with this medication.

Dosage and Administration

You should take this medication by mouth in the form of softgels. If you are an adult or a child aged 12 years and older, you can take 2 softgels every 6 to 8 hours as needed. However, make sure not to exceed 8 softgels in a 24-hour period.

It's important to note that this product is not suitable for children under 12 years of age, so if you have younger children, do not use it for them. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before taking this product.

Taking this medication while on an MAOI can lead to serious health risks, so please prioritize your safety by following these guidelines closely.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, do not use this medication, and wait at least two weeks after stopping the MAOI before starting it.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these could indicate a more serious health issue. Additionally, if you have a cough with excessive mucus or a chronic cough due to smoking, asthma, or emphysema, it's important to talk to your doctor before using this medication.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

Before using this medication, it's important to talk to your doctor if you have a cough that produces a lot of mucus or if you have a chronic cough due to smoking, asthma, or emphysema. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious condition.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your health and safety are important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help as soon as you notice any concerning symptoms.

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

This product is specifically designed for adults and should not be used in children under 12 years of age. If your child is younger than 12, it is important to avoid using this medication altogether. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This medication is designed for adults and is not suitable for children under 12 years old. For older adults, there are no specific dosage adjustments or safety concerns noted, which means you can generally use it as directed without needing to change the amount you take. However, it's always a good idea to discuss any medications with your healthcare provider, especially if you have other health conditions or are taking multiple medications. Your doctor can help ensure that this treatment is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when taking dextromethorphan, especially if you are also using prescription medications known as monoamine oxidase inhibitors (MAOIs). Combining these two can lead to serious interactions, so you should avoid using dextromethorphan for at least two weeks after stopping an MAOI.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potential complications. They can help you understand how different drugs may interact and guide you on the best course of action for your health.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25ºC (68-77ºF). It's important to avoid exposing it to excessive heat, particularly temperatures above 40ºC (104ºF), as this can compromise its effectiveness. Additionally, make sure to protect the product from light to maintain its quality.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug temporarily relieves cough due to minor throat and bronchial irritation that may occur with a cold.

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

Adults and children 12 years and over should take 2 softgels every 6 to 8 hours as needed, but do not exceed 8 softgels in a 24-hour period.

Is this product safe for children under 12?

No, this adult product is not intended for use in children under 12 years of age.

What should I do if my cough lasts more than 7 days?

Stop use and ask a doctor if your cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Are there any contraindications for using this drug?

Do not use this drug if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I am pregnant or breastfeeding?

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

How should I store this medication?

Store at 20-25ºC (68-77ºF) and avoid excessive heat above 40ºC (104ºF). Protect from light.

Packaging Info

Below are the non-prescription pack sizes of Goodmeds Non-Drowsy Cough Relief (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goodmeds Non-Drowsy Cough Relief.
Details

Drug Information (PDF)

This file contains official product information for Goodmeds Non-Drowsy Cough Relief, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 softgels taken orally every 6 to 8 hours, as needed. It is imperative that the total dosage does not exceed 8 softgels within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, administration in this population is contraindicated.

Healthcare professionals should ensure that patients are aware of the appropriate dosing intervals and the maximum daily limit to prevent potential overdose.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s prescription includes an MAOI by consulting with the patient or referring them to a pharmacist.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they present with a cough that is productive of excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks. The use of this medication in such cases is contraindicated.

Common adverse reactions include the potential for a persistent cough. Patients are advised to stop use and consult a healthcare professional if their cough lasts for more than 7 days, returns, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Before initiating treatment, patients should seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

Dextromethorphan is contraindicated for use in conjunction with prescription monoamine oxidase inhibitors (MAOIs) due to the potential for serious interactions. It is advised that dextromethorphan not be administered for a period of two weeks following the discontinuation of an MAOI to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been identified for dextromethorphan. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Goodmeds Non-Drowsy Cough Relief (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goodmeds Non-Drowsy Cough Relief.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may use this adult product; however, it is not intended for use in children under 12 years of age. The prescribing information does not specify any dosage adjustments or safety concerns unique to geriatric patients.

Healthcare providers should continue to monitor elderly patients for any potential adverse effects, as individual responses to medication can vary with age. It is advisable to exercise caution and consider the overall health status and comorbidities of geriatric patients when prescribing this medication.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that the following adverse reactions have been reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and gastrointestinal disturbances. These events were documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Goodmeds Non-Drowsy Cough Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Goodmeds Non-Drowsy Cough Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.