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Dometuss-G

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This product has been discontinued

Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 20 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 20 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Dosage form
Tablet
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 2019
Label revision date
December 6, 2024
Manufacturer
DOMEL
Registration number
M012
NDC root
53809-250
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

DOMETUSS-G is a combination medication that includes dextromethorphan HBr (a cough suppressant), phenylephrine HCl (a nasal decongestant), and guaifenesin (an expectorant). It is designed to help relieve symptoms associated with the common cold, hay fever, or other upper respiratory allergies.

This medication works by calming the cough control center in your brain to reduce coughing, loosening phlegm (mucus) to make coughs more productive, and temporarily relieving nasal congestion and sinus pressure. With DOMETUSS-G, you can find relief from the discomfort of a cough and nasal congestion, helping you feel more comfortable during cold and allergy seasons.

Uses

This medication can help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions, which allows for more productive coughs. If you're dealing with a cold, it can temporarily reduce your cough caused by minor throat and bronchial irritation.

Additionally, it works to calm the cough control center in your body, providing relief from persistent coughing. If you're experiencing nasal congestion from a cold, hay fever, or other upper respiratory allergies, this medication can help clear that up as well. It also alleviates sinus congestion and pressure, making it easier for you to feel comfortable.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 1 tablet every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If you're giving this medication to children between the ages of 6 and 12, the dosage is 1/2 tablet every 4 hours, also not exceeding 6 doses in a day.

For children under 6 years of age, it's crucial to consult a doctor before administering this medication. This ensures that the child receives the appropriate care and dosage tailored to their specific needs. Always keep track of how many doses you've taken to avoid taking too much.

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, you should 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 using 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

It's important to be aware of potential side effects when using this product. You should not exceed the recommended dosage. If you experience nervousness, dizziness, or sleeplessness, stop using the product and consult your doctor. Avoid using this product if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless directed by a doctor.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you notice new symptoms, if your symptoms do not improve within 7 days, or if you experience pain or fever that persists or worsens, stop using the product and seek medical advice, as these could indicate a more serious condition.

Warnings and Precautions

It's important to use this product safely. Always stick to the recommended dosage, and if you experience nervousness, dizziness, or sleeplessness, stop using it and consult your doctor. Avoid using this product if you are currently taking a prescription Monoaminoxidase Inhibitor (MAOI) or have taken one in the past two weeks. If you have a persistent cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus, do not use this product unless directed by a doctor.

You should also refrain from using this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless your doctor advises otherwise. If you have liver disease or are taking the blood thinner warfarin, consult your doctor before use. If you notice new symptoms, if your symptoms do not improve within 7 days, or if you develop a fever, stop using the product and contact your doctor, as these could indicate a more serious issue.

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 whether an overdose has occurred, seek immediate medical help. Always prioritize your safety and well-being by adhering to the recommended dosage.

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

When it comes to giving this medication to children, it's important to follow specific guidelines. For children aged 6 to 12 years, the recommended dosage is half a tablet every four hours. However, if your child is under 6 years old, you should consult a doctor before administering the medication. This ensures that you receive the best advice tailored to your child's needs. Always prioritize safety and seek professional guidance when it comes to younger children.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related considerations, dosage adjustments, or safety precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if it’s safe for you and whether any adjustments to your dosage are necessary. Monitoring your liver function may also be required to ensure your safety while using this treatment. Always prioritize open communication with your healthcare team regarding your liver health.

Drug Interactions

It's important to be cautious about drug interactions when considering new medications. If you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI)—which is a type of medication used for depression, certain psychiatric conditions, or Parkinson's disease—you should not use this medication. Additionally, you should wait at least two weeks after stopping an MAOI before starting this new treatment.

If you are taking warfarin, a blood-thinning medication, it's essential to consult your doctor before using this drug. Always discuss any medications or tests with your healthcare provider to ensure your safety and avoid potential interactions.

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 product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is DOMETUSS-G used for?

DOMETUSS-G is a cough suppressant, nasal decongestant, and expectorant that helps relieve cough, nasal congestion, and sinus pressure.

What are the active ingredients in DOMETUSS-G?

The active ingredients are Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin.

How should I take DOMETUSS-G?

Adults and children 12 years and over should take 1 tablet every 4 hours, while children 6 to 12 years should take 1/2 tablet every 4 hours. Consult a doctor for children under 6.

Are there any contraindications for using DOMETUSS-G?

Do not use DOMETUSS-G if you are taking a prescription Monoaminoxidase Inhibitor (MAOI) or have certain conditions like heart disease, high blood pressure, or thyroid disease without consulting a doctor.

What should I do if I experience side effects?

If you experience nervousness, dizziness, or sleeplessness, discontinue use and consult a doctor.

Can I use DOMETUSS-G if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using DOMETUSS-G.

What should I do if my symptoms do not improve?

Stop using DOMETUSS-G and consult a doctor if new symptoms occur, symptoms do not improve within 7 days, or if pain or fever persists or worsens.

How should I store DOMETUSS-G?

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

Packaging Info

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

Packaging configurations for Dometuss-G.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DOMETUSS-G is a combination medication containing Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin. It is formulated as a cough suppressant, nasal decongestant, and expectorant. The product is available in a dosage form of tablets, with a total count of 100 tablets per package. The National Drug Code (NDC) for this product is 53809-250-01.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and making coughs more productive.

Additionally, this drug temporarily reduces cough due to minor throat and bronchial irritation associated with a cold and calms the cough control center to relieve coughing. It also provides temporary relief from nasal congestion due to the common cold, hay fever, or other upper respiratory allergies. Furthermore, it alleviates sinus congestion and pressure.

Limitations of use include the necessity for careful consideration in patients with specific respiratory conditions or those who may be sensitive to the active ingredients.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours, with a maximum of 6 doses within a 24-hour period. For children aged 6 to 12 years, the recommended dosage is 1/2 tablet every 4 hours, also not exceeding 6 doses in a 24-hour period.

For children under 6 years of age, it is essential to consult a healthcare professional before administration.

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 two weeks following the discontinuation of an MAOI. Patients uncertain about their medication status regarding MAOIs should consult a healthcare professional prior to using this product.

Warnings and Precautions

The recommended dosage should not be exceeded to avoid potential adverse effects. In the event of nervousness, dizziness, or sleeplessness, it is imperative to discontinue use and consult a healthcare professional.

General precautions must be observed prior to use. This product should not be taken concurrently with prescription Monoamine Oxidase Inhibitors (MAOIs), which are medications used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the cessation of an MAOI. If there is uncertainty regarding the presence of an MAOI in any current prescription medication, consultation with a doctor or pharmacist is essential.

This product is contraindicated in individuals with certain medical conditions, including heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to prostate gland enlargement, unless directed by a healthcare provider. Furthermore, individuals with liver disease or those taking the anticoagulant warfarin should seek medical advice before using this product.

Patients are advised to stop using this product and contact a healthcare professional if new symptoms arise, if symptoms do not improve within seven days, or if they are accompanied by fever. Persistent or worsening pain or fever may indicate a serious underlying condition that requires immediate medical attention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with pre-existing health conditions. It is crucial not to exceed the recommended dosage, as doing so may lead to increased risk of adverse effects. Patients experiencing nervousness, dizziness, or sleeplessness should discontinue use and consult a healthcare professional.

This product is contraindicated in patients currently taking a prescription Monoaminoxidase Inhibitor (MAOI) or within two weeks of stopping such medication. Additionally, it should not be administered to individuals with heart disease, high blood pressure, thyroid disease, or diabetes, particularly if they have difficulty urinating due to prostate gland enlargement, unless directed by a physician.

Patients with liver disease or those taking the anticoagulant warfarin should seek medical advice before using this product. It is advised to stop using the product and consult a doctor if new symptoms arise, if symptoms do not improve within seven days, or if they are accompanied by fever. Persistent or worsening pain or fever may indicate a serious underlying condition that requires medical attention.

Drug Interactions

The concomitant use of this medication with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking a prescription MAOI or for a period of two weeks following the discontinuation of the MAOI treatment. This interaction may lead to serious adverse effects due to the potential for hypertensive crises or other severe reactions.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a commonly prescribed anticoagulant. Patients are encouraged to consult with their healthcare provider prior to initiating this medication if they are currently on warfarin therapy. Monitoring of coagulation parameters may be warranted to ensure patient safety and to mitigate the risk of bleeding complications.

Packaging & NDC

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

Packaging configurations for Dometuss-G.
Details

Pediatric Use

Pediatric patients aged 6 to 12 years may be administered 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor prior to use. Caution should be exercised when considering treatment in this younger age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety may be warranted, given the general variability in drug response among elderly individuals.

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 considered, 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 safe use during pregnancy and lactation.

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 drug insert 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 should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and clearance. Monitoring of liver function may be necessary to ensure safety and efficacy in this population.

Overdosage

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly to the recommended dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient closely for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific medication involved and may include a range of physiological and psychological effects.

Management of overdosage should be initiated promptly. Healthcare professionals are advised to provide supportive care and symptomatic treatment as necessary. In cases where the overdosage is significant, further medical intervention may be required, including the possibility of activated charcoal administration if appropriate and within the recommended time frame post-ingestion.

It is essential to consult local poison control centers or relevant medical authorities for guidance on specific management protocols tailored to the medication in question. Continuous assessment and monitoring of the patient’s condition are vital to ensure optimal outcomes following an overdosage incident.

Nonclinical Toxicology

If you are 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is crucial to inform patients that they should not use this product if they are currently taking a prescription Monoaminoxidase Inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should also be instructed not to use this product for two weeks after stopping an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist before using this product.

Patients should be informed to discontinue use and seek medical advice if new symptoms arise. Additionally, they should be advised to stop using the product and consult a doctor if their symptoms do not improve within 7 days or if they experience symptoms accompanied by fever. It is important to highlight that persistent or worsening pain or fever may indicate a serious condition, warranting immediate medical attention.

Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease or if they are taking the blood-thinning medication warfarin. This precaution is essential to ensure the safe and effective use of the product.

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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Dometuss-G, 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-G, 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

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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.