Symptom checker
Select audience type

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

ADD CONDITION

items per page

Long Acting Cough Softgels

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
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 2022
Label revision date
December 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
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 2022
Label revision date
December 16, 2024
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
M012
NDC root
63868-824
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 cough caused by minor irritation in the throat and bronchial tubes, which can happen during a cold. It helps soothe your throat and reduce the urge to cough, making you feel more comfortable. If you're experiencing a cough due to a cold, this product may provide the relief you need.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens when you have a cold. It helps soothe your symptoms, making it easier for you to feel comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your cough during a cold.

Dosage and Administration

You should be careful when taking this medication. Adults and children aged 12 years and older can take 2 softgels every 6 to 8 hours as needed, but make sure not to exceed 8 softgels in a 24-hour period. This means you can use the medication multiple times throughout the day, but always keep track of how many you’ve taken to avoid taking too much.

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

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

You should avoid using this medication if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. It's important to consult a doctor before using this medication if you have a cough with excessive mucus, a chronic cough due to smoking, asthma, or emphysema.

If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and seek medical advice, as these could indicate a more serious issue. Additionally, if you are pregnant or breastfeeding, please consult a healthcare professional before use. In case of an overdose, seek medical help immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

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 other conditions. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have a cough that produces a lot of phlegm (mucus) or if your cough is chronic, such as from smoking, asthma, or emphysema. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these could be signs of a more serious condition. If you are pregnant or breastfeeding, please consult a healthcare professional before use.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Quick medical attention is essential for both adults and children, even if you do not notice any symptoms.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about a possible overdose, don’t hesitate to get help right away. Your prompt action can make a significant difference in ensuring safety and health.

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 you have a child who is younger than 12, it is important to avoid using this medication for their safety. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This product is designed for adults and is not suitable for children under 12 years old. If you are an older adult and have a cough that produces a lot of mucus or a chronic cough due to conditions like smoking, asthma, or emphysema, it’s important to consult your doctor before using this medication.

You should also stop using the product and seek medical advice if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious health issue. In the event of an overdose, it’s crucial to get medical help immediately or contact a Poison Control Center, even if you don’t notice any symptoms. Your health and safety are the top priority.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you make informed decisions about your treatment options.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), 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 should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 to 8 hours as needed. However, if your child is under 12 years old, do not use this medication. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the purpose of this medication?

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

Who can use this medication?

Adults and children 12 years and older can use this medication. It is not intended for children under 12 years of age.

What is the recommended dosage for adults and children 12 years and older?

You should take 2 softgels every 6 to 8 hours as needed, but do not exceed 8 softgels in any 24-hour period.

What should I do in case of an overdose?

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

Are there any warnings I should be aware of?

Do not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if you have a cough with too much phlegm or a chronic cough.

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

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

Is it safe to use this medication during pregnancy or breastfeeding?

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

How should I store this medication?

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

Packaging Info

Below are the non-prescription pack sizes of Long Acting Cough Softgels (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Long Acting Cough Softgels.
Details

Drug Information (PDF)

This file contains official product information for Long Acting Cough Softgels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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

Adults and children aged 12 years and older are advised to take 2 softgels every 6 to 8 hours as needed. It is important not to exceed a total of 8 softgels within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it should not be administered to this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or 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 should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Prior to use, patients should seek medical advice if they have a cough that is associated with excessive phlegm (mucus) or if they experience a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients are advised 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 serious medical condition that requires further evaluation.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients should be aware of several important warnings and adverse reactions associated with the use of this medication. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. Patients are advised to consult a healthcare professional prior to use if they have a cough that produces excessive phlegm, or if they experience a chronic cough related to smoking, asthma, or emphysema.

Patients should discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional before using this medication.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are initially apparent.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Long Acting Cough Softgels (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Long Acting Cough Softgels.
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 within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients should be aware that this adult product is not intended for use in individuals under 12 years of age. It is advisable for geriatric patients to consult a healthcare provider prior to use, particularly if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as may occur with conditions such as smoking, asthma, or emphysema.

In the event that a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, elderly patients should discontinue use and seek medical advice. These symptoms may indicate a serious underlying condition that requires prompt evaluation.

Additionally, in cases of overdose, it is crucial for elderly patients to seek immediate medical assistance or contact a Poison Control Center. Timely medical attention is essential, regardless of whether any signs or symptoms of overdose are present.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to communicate the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately. Emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its efficacy and stability.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 to 8 hours as needed. It is contraindicated for use in children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Long Acting Cough Softgels, 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 Long Acting Cough Softgels, 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.