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Dometuss-Dm

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Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 5, 2024
Manufacturer
Domel Laboratories
Registration number
M012
NDC root
53809-201
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

DOMETUSS-DM is an expectorant and cough suppressant that helps you manage coughs associated with minor throat and bronchial irritation, which can occur during a cold. It works by loosening phlegm (mucus) and thinning bronchial secretions, making your coughs more productive and easier to expel.

This medication is alcohol and sugar-free, and it comes in a pleasant grape flavor, making it a suitable option for those looking for relief without added sugars or alcohol.

Uses

If you're dealing with a cough caused by a cold or minor irritation in your throat and bronchial area, this medication can help. It works by loosening phlegm (mucus) and thinning out bronchial secretions, making your coughs more productive. This means that you can clear out mucus more effectively, which can provide some relief.

In addition to helping with mucus, it also temporarily relieves coughs that may arise from minor throat and bronchial irritation. This can make it easier for you to breathe and feel more comfortable while you recover.

Dosage and Administration

When taking this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. If you are an adult or a child aged 12 years and older, you should take 1 teaspoonful (5 mL) every 6 hours. For children aged 6 to under 12 years, the dosage is 1/2 teaspoonful (2.5 mL) every 6 hours.

Make sure not to exceed more than 4 doses in any 24-hour period unless your doctor advises otherwise. If your child is under 6 years old, it's best to consult a doctor before giving them this medication. Always follow these guidelines to help manage your health effectively.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, such as those caused by smoking, asthma, or emphysema, especially if your cough is accompanied by excessive phlegm (mucus). It's important to consult a doctor before using this product in such cases. Additionally, do not use this product if you are currently taking a prescription Monoaminooxidase 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 ask your doctor or pharmacist for guidance.

Side Effects

It's important to be aware of potential side effects when taking this medication. You should not exceed the recommended dosage, as doing so can lead to serious health issues. Additionally, if you experience a persistent cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, it's crucial to consult your doctor. These could be signs of a more serious condition that needs attention.

Warnings and Precautions

It's important to follow the recommended dosage for this medication and not exceed it. If you develop a persistent cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, you should consult your doctor, as this could indicate a serious condition.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Taking these precautions can help ensure your safety while using this medication.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause harmful effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms or if you are unsure, seek immediate medical help. Always err on the side of caution—it's better to get checked out than to take risks with your health.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on whether it is safe for you and your baby. Always prioritize your health and the health of your child by seeking professional 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

When giving this medication to your child, it's important to follow the recommended dosages based on their age. For adults and children aged 12 years and older, the dosage is 1 teaspoonful (5 mL) every 6 hours. If your child is between 6 and 12 years old, they should take 1/2 teaspoonful (2.5 mL) every 6 hours.

For children under 6 years of age, you should consult a doctor before administering this medication. This ensures that you are making the safest choice for your child's health. Always adhere to these guidelines to help keep your child safe and healthy.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment. This means that there are no tailored recommendations for how your kidney condition might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help determine the best approach 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's crucial to be aware of potential interactions when considering any medication. If you are currently taking a prescription Monoaminooxidase Inhibitor (MAOI), which is a type of medication used for depression, certain 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 product. If you're unsure whether your current medication includes an MAOI, it's important to consult with your doctor or pharmacist.

Always discuss any medications or treatments with your healthcare provider to ensure they are safe and appropriate for you. This helps prevent any harmful interactions and supports your overall health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15° and 30°C (59° and 86°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, follow those carefully to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is DOMETUSS-DM?

DOMETUSS-DM is an expectorant and cough suppressant that is alcohol and sugar-free, available in grape flavor.

How does DOMETUSS-DM work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving coughs due to minor throat and bronchial irritation.

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

Adults and children 12 years and older should take 1 teaspoonful (5 mL) every 6 hours, not exceeding 4 doses in 24 hours.

What is the dosage for children aged 6 to under 12?

Children aged 6 to under 12 should take 1/2 teaspoonful (2.5 mL) every 6 hours.

What should I do if my child is under 6 years old?

If your child is under 6 years old, you should ask a doctor before use.

Are there any contraindications for using DOMETUSS-DM?

Do not use this product for persistent or chronic coughs, or if you are taking a prescription Monoaminooxidase Inhibitor (MAOI) or have excessive phlegm, unless directed by a doctor.

What should I do in case of overdose?

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

What precautions should I take if I am pregnant or breastfeeding?

Consult a health professional before using DOMETUSS-DM if you are pregnant or breastfeeding.

What should I do if my cough persists?

If your cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

How should I store DOMETUSS-DM?

Store DOMETUSS-DM at room temperature between 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Dometuss-Dm (guaifenesin, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dometuss-Dm.
Details

Drug Information (PDF)

This file contains official product information for Dometuss-Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

DOMETUSS-DM is an expectorant and cough suppressant formulated without alcohol and sugar. It is presented in a liquid dosage form with a grape flavor. The product is packaged in a 1 fluid ounce container. The National Drug Code (NDC) for DOMETUSS-DM is 53809-201-01. This product is manufactured for DOMEL, located in San Juan, Puerto Rico, 00924. The most recent revision of this labeling was completed in October 2013.

Uses and Indications

This drug is indicated for the relief of coughs associated with minor throat and bronchial irritation, which may occur due to a cold. It helps to loosen phlegm (mucus) and thin bronchial secretions, thereby making coughs more productive.

Limitations of Use: This medication is intended for temporary relief and should not be used as a long-term treatment for chronic cough conditions.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in any 24-hour period, unless otherwise directed by a physician. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 6 hours, also adhering to the maximum limit of 4 doses within a 24-hour timeframe. For children under 6 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with persistent or chronic cough, including those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional. This is due to the potential for exacerbating underlying conditions.

Additionally, the product should not be used in conjunction with prescription Monoaminooxidase Inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Use is contraindicated while taking an MAOI and for two weeks following the cessation of MAOI therapy. If there is uncertainty regarding the presence of an MAOI in a current medication regimen, consultation with a healthcare provider is advised.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Warnings It is imperative that the recommended dosage is not exceeded. A persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, the patient should be advised to consult a physician promptly.

General Precautions In the event of an overdose, immediate medical assistance should be sought. Healthcare providers should instruct patients to contact a Poison Control Center without delay if an overdose is suspected.

Emergency Medical Help Instructions In cases of overdose, it is crucial to obtain emergency medical help or to contact a Poison Control Center immediately.

No specific laboratory tests are recommended for monitoring in relation to this medication.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious complications.

A persistent cough may indicate a serious underlying condition. If patients experience a cough that persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, they are advised to consult a healthcare professional promptly. This caution is essential to ensure timely evaluation and management of any serious health issues that may arise.

Drug Interactions

The concomitant use of this product with Monoaminooxidase Inhibitors (MAOIs) is contraindicated. MAOIs are a class of medications commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not use this product while taking an MAOI or for a period 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, if they are uncertain about whether their current prescription medications include an MAOI. This precaution is critical to avoid potential adverse effects associated with the interaction between this product and MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Dometuss-Dm (guaifenesin, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dometuss-Dm.
Details

Pediatric Use

Pediatric patients aged 12 years and older are recommended to take 1 teaspoonful (5 mL) every 6 hours. For children aged 6 to under 12 years, the dosage is 1/2 teaspoonful (2.5 mL) every 6 hours. For children under 6 years of age, it is advised to consult a doctor before administration.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 evaluated in these populations to ensure maternal and fetal safety.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment 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 overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Healthcare professionals should be vigilant in monitoring patients for any signs of overdosage, which may manifest as an exacerbation of known side effects or the emergence of new symptoms.

Recommended Actions

In cases of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider the following management procedures:

  1. Assessment of Symptoms: Monitor the patient for any acute symptoms that may arise due to overdosage. This may include, but is not limited to, increased severity of side effects associated with the medication.

  2. Supportive Care: Provide supportive care as necessary, which may involve symptomatic treatment and monitoring of vital signs.

  3. Consultation with Poison Control: It is advisable to contact a poison control center for guidance on specific management strategies tailored to the substance involved in the overdosage.

  4. Documentation: Ensure thorough documentation of the incident, including the dosage taken, time of ingestion, and any symptoms observed.

Healthcare professionals are reminded to educate patients on the importance of adhering to prescribed dosages to mitigate the risk of overdosage and its potential complications.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised that health professionals be consulted prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dometuss-Dm, 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 Dometuss-Dm, 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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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.