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Mucus Relief

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
March 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Dosage form
Solution
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 2024
Label revision date
March 8, 2025
Manufacturer
TOPCO ASSOCIATES LLC
Registration number
M012
NDC root
76162-057
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

TopCare® Children's Multi-Symptom Cold Mucus Relief is an oral solution designed for children aged 4 to 11 years. This medication contains three active ingredients: dextromethorphan HBr, which acts as a cough suppressant; guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions; and phenylephrine HCl, a nasal decongestant. Together, these ingredients work to temporarily relieve cough due to minor throat and bronchial irritation, nasal congestion from a cold, and the intensity of coughing, making it easier for your child to breathe and sleep.

This product is available in a pleasant berry flavor and comes in a 6.8 FL OZ (201 mL) bottle. It is specifically formulated to help your child feel more comfortable during cold symptoms by clearing mucus and reducing coughing.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

You can use this medication to temporarily relieve a cough caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps with nasal congestion due to a cold, reduces the intensity of coughing, alleviates a stuffy nose, and can even help reduce the urge to cough, making it easier for children to sleep.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should never take more than the directed amount, and you should not exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours. If your child is between 4 and under 6 years old, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, you should not use this medication. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific medications used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

Always follow the recommended dosage and never exceed it, as misuse can lead to serious health issues. Remember, taking medications responsibly is crucial for your child's safety and well-being.

Side Effects

If you experience nervousness, dizziness, or trouble sleeping while using this medication, it's important to stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if they occur alongside a fever, you should seek medical advice. A cough that lasts more than 7 days, keeps coming back, or is accompanied by a fever, rash, or a persistent headache may indicate a more serious health issue, and you should contact your healthcare provider.

Warnings and Precautions

It's important to be cautious when using this medication, especially for children. Do not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, check with a doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a chronic cough (like asthma), or a cough with excessive mucus. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days, stop using the medication and contact a doctor. Additionally, if a cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice as these may indicate a more serious issue. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an 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 are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy and be aware of the signs that indicate you need urgent assistance. Your health is important, so don’t hesitate to reach out for help if you think you’ve taken too much of a medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to know that the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, but specific studies or data are not available to clarify these risks. Therefore, it is crucial to consult your doctor before using this product.

Additionally, there are no specific dosage modifications mentioned for pregnant individuals, but seeking medical advice is strongly recommended to ensure your safety and that of your baby. Always prioritize open communication with your healthcare provider regarding any medications or products you consider using during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your child.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using it, consult your doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a chronic cough (like asthma), or a cough with excessive mucus.

For dosing, children aged 6 to under 12 years can take 10 mL every 4 hours, while those aged 4 to under 6 years should take 5 mL every 4 hours. It's crucial not to exceed these recommended doses. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days, you should stop using the medication and consult a doctor. Additionally, if a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 when considering medications for your child, especially if they are currently taking or have recently stopped a prescription monoamine oxidase inhibitor (MAOI). MAOIs are specific drugs used to treat depression, certain psychiatric conditions, or Parkinson’s disease. You should not use this medication in a child who is on an MAOI or for at least two weeks after they have stopped taking it. If you're unsure whether your child's prescription includes an MAOI, please consult with a doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and avoid potential interactions. Your provider can help you understand the risks and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the end flap for the expiration date and lot number, as this information is crucial for your safety and the product's effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling will help you use the product safely and effectively.

Additional Information

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

FAQ

What is TopCare® Children's Multi-Symptom Cold Mucus Relief?

It is an oral solution designed for children ages 4 to 11 years, containing active ingredients like Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant).

What symptoms does this medication relieve?

It temporarily relieves cough due to minor throat and bronchial irritation, nasal congestion, the intensity of coughing, stuffy nose, and the impulse to cough to help your child sleep.

What is the recommended dosage for children?

For children 6 to under 12 years, the dosage is 10 mL every 4 hours; for children 4 to under 6 years, it is 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this product?

Do not use in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if unsure.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is potential for excretion in breast milk.

How should this medication be stored?

Store at 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F).

Packaging Info

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

Packaging configurations for Mucus Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

+TopCare® Children's Multi-Symptom Cold Mucus Relief is an oral solution formulated for children aged 4 to 11 years. The product contains three active ingredients: Dextromethorphan HBr, which serves as a cough suppressant; Guaifenesin, an expectorant that aids in breaking up mucus; and Phenylephrine HCl, a nasal decongestant that relieves stuffy noses. The solution is presented in a 6.8 FL OZ (201 mL) volume and is flavored with berry.

The product is indicated for the control of cough, relief of chest congestion, and alleviation of nasal congestion. A tamper evident warning is included, stating that the product should not be used if the imprinted safety seal under the cap is broken or missing. It is distributed by Topco Associates LLC, located in Itasca, IL 60143.

Uses and Indications

This drug is indicated for the relief of cough and nasal congestion associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and provides relief from a stuffy nose, which may assist children in achieving restful sleep by reducing the impulse to cough.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits, and no more than six doses should be administered within a 24-hour period. It is essential to utilize only the dose cup provided with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dosage is 10 mL every 4 hours as needed. For children aged 4 to under 6 years, the appropriate dosage is 5 mL every 4 hours. The medication is not recommended for use in children under 4 years of age.

Healthcare providers should ensure that caregivers understand these guidelines to prevent any potential overdose or misuse of the medication.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise parents or guardians to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate special consideration or alternative treatment options.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Parents or guardians should be instructed to discontinue use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further evaluation is warranted. A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and requires prompt medical attention.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought. A persistent cough lasting more than 7 days, especially if it recurs or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days following the discontinuation of such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is strongly recommended.

Packaging & NDC

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

Packaging configurations for Mucus Relief.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past 2 weeks. Prior to use, it is advisable to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as occurs with asthma), or cough associated with excessive phlegm.

Dosage recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 to under 6 years, the dose is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age. It is important not to exceed the recommended dosage.

Parents or caregivers should discontinue use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned. It is strongly advised that medical advice be sought prior to using this product during pregnancy to ensure the health and safety of both the patient and the fetus.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the 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 the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, they should seek medical advice, as these may indicate a serious condition.

It is important to emphasize that patients must not exceed the recommended dosage while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. 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).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

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

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

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

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

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

No human clinician has reviewed this version.

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.