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Mucus Relief Xpect

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Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2021
Label revision date
October 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2021
Label revision date
October 17, 2024
Manufacturer
Selder, S. A. de C. V.
Registration number
M012
NDC root
63654-342
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

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear your airways more effectively.

Additionally, this drug provides temporary relief from coughs caused by minor sore throat and bronchial irritation that often accompany the common cold. It can be a helpful option when you're dealing with these uncomfortable symptoms.

Uses

This medication is designed to help you manage your cough and respiratory discomfort. It works by loosening phlegm (mucus) and thinning bronchial secretions, which can make your coughs more productive. This means that when you do cough, it can help clear out mucus more effectively.

Additionally, it provides temporary relief from coughs caused by minor sore throats and bronchial irritation that often accompany the common cold. If you're dealing with these symptoms, this medication may help you feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed while your symptoms last. It’s important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 doses in a 24-hour period to avoid any potential side effects.

For children under 12 years of age, this medication is not recommended, so please do not use it for younger children. 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 are medications often prescribed for depression, psychiatric, or emotional conditions, or for Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's important to be aware that misuse or abuse of this product can lead to dependence (a condition where your body becomes reliant on a substance). Always follow these guidelines to ensure your safety and well-being.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you have a cough that produces a lot of mucus or a persistent cough due to smoking, asthma, or other lung conditions, consult your doctor before using this product.

If your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. Additionally, if you are pregnant, breastfeeding, or taking sedatives or tranquilizers, it's important to talk to a healthcare professional before use. Always keep this medication out of reach of children, and in case of accidental overdose, seek immediate medical help or contact a Poison Control Center.

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, 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 product, it's important to talk to your doctor if you have a cough with excessive mucus, a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if you are taking sedatives or tranquilizers, check with your doctor or pharmacist first.

You should stop using this product and contact your doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious issue. In the event of an accidental overdose, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention.

Always err on the side of caution—if you think you or someone else has taken too much of a medication, don’t wait. Getting timely assistance 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

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. For those who are 12 years and older, the dosage is one tablet every four hours as needed, accompanied by a full glass of water. However, be cautious not to exceed six doses within a 24-hour period to ensure safety and effectiveness. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 should be used 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 you understand how to manage your treatment effectively while considering your kidney 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 should be used if you have hepatic impairment (issues with liver function).

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 about potential interactions with other medications. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or certain emotional conditions. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication includes an MAOI, it's best to consult with your doctor or pharmacist.

Before using this product, also check with your healthcare provider if you are taking sedatives or tranquilizers, as these can interact with the medication. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F), but make sure to keep it in a dry place and away from heat sources.

When handling the product, check the blister package carefully before use. If the package is torn or damaged, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with adults and children aged 12 and older advised to take 1 tablet every 4 hours as needed, while ensuring not to exceed 6 doses in a 24-hour period. If you are under 12 years old, do not use this medication. It's important to take it with a full glass of water.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Always keep it out of reach of children, and in the event of an accidental overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It also temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

Who can take this drug?

Adults and children 12 years and older can take this drug. Children under 12 years of age should not use it.

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

The recommended dosage is 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 doses in 24 hours.

Are there any contraindications for 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. Consult a doctor or pharmacist if unsure.

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

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

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

If you are pregnant or breastfeeding, ask a health professional before using this drug.

What should I do in case of accidental overdose?

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

What precautions should I take before using this drug?

Ask a doctor before use if you have a cough with excessive phlegm, a persistent cough, or if you are taking sedatives or tranquilizers.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief Xpect (guaifensin, dextromethorphan). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief Xpect.
Details

Drug Information (PDF)

This file contains official product information for Mucus Relief Xpect, 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 relief of cough associated with minor sore throat and bronchial irritation due to the common cold. It helps to loosen phlegm (mucus) and thins bronchial secretions, thereby making coughs more productive.

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

Dosage and Administration

Adults and children 12 years and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential to administer the tablet with a full glass of water. The maximum allowable dosage is 6 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

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 they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should exercise caution and advise patients to seek medical consultation before using this product if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking sedatives or tranquilizers should also consult with a doctor or pharmacist before using this product.

Patients are instructed to discontinue use and contact their healthcare provider 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.

In the event of an accidental overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients should consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions include the need for caution in patients with a cough accompanied by excessive phlegm or those with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. Patients are advised to stop using the product 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, patients taking sedatives or tranquilizers should consult a doctor or pharmacist before using this product. Pregnant or breastfeeding individuals are also advised to seek professional guidance prior to use.

It is crucial to keep this product out of the reach of children. In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on a prescription 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 if they are uncertain whether their prescription medication contains an MAOI.

Additionally, caution is advised when considering the use of this product in conjunction with sedatives or tranquilizers. Patients should seek guidance from a healthcare provider or pharmacist prior to use to ensure safety and appropriate management of potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Xpect (guaifensin, dextromethorphan). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief Xpect.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed, taken with a full glass of water. It is important not to exceed 6 doses within a 24-hour period while symptoms persist.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 revealed reports of several adverse reactions associated with the use of the product. These include dizziness, nausea, and vomiting. Additionally, there have been reports of allergic reactions, which encompass rash, pruritus, and urticaria. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease. They should also refrain from 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 use.

Healthcare providers should instruct patients to stop using the medication and seek medical advice 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 condition.

Additionally, patients should be advised to consult with their doctor before using this medication if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may occur with smoking, asthma, chronic bronchitis, or emphysema.

Finally, patients should be encouraged to speak with their doctor or pharmacist before using this medication if they are currently taking sedatives or tranquilizers, to ensure safe and effective use.

Storage and Handling

The product is supplied in a blister package. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to keep the product in a dry place and to avoid exposure to heat. Healthcare professionals are advised not to use the product if the blister package is torn or damaged, as this may compromise the integrity of the medication.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, not to exceed six doses within a 24-hour period. It is advised that children under 12 years of age should not use this medication.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the medication out of reach of children, and in the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Mucus Relief Xpect, 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 Mucus Relief Xpect, 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.