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Dg Health Childrens Mucus Relief

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This product has been discontinued

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 2015
Label revision date
November 12, 2024
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 2015
Label revision date
November 12, 2024
Manufacturer
Dolgencorp Inc
Registration number
M012
NDC root
55910-839
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

Children’s Mucus Relief is a medication designed for children aged 4 to 12 years, formulated to help alleviate symptoms associated with colds and respiratory issues. It contains three active ingredients: guaifenesin (an expectorant that helps loosen phlegm and thin bronchial secretions), dextromethorphan HBr (a cough suppressant that temporarily relieves cough due to throat and bronchial irritation), and phenylephrine HCl (a nasal decongestant that reduces nasal congestion).

This medication works by breaking up mucus, making coughs more productive, and reducing the urge to cough, which can help children sleep better. It also addresses stuffy noses and chest congestion, providing relief from the discomfort often caused by colds.

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 bronchial passageways, making your coughs more productive.

You can use this medication to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps reduce the intensity of your cough and the urge to cough, making it easier for your child to sleep. Additionally, it can relieve nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

It's important to follow the correct dosage when using this medication to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, always use the dosing cup that comes with the medication, and avoid using it with any other products to prevent confusion.

For children aged 6 years to under 12 years, the recommended dose is 10 mL every 4 hours. If your child is between 4 years and under 6 years, 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 using this medication. You should not give it to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are certain medications used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, do not use this medication for at least two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Always follow the dosage instructions carefully and do not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Your safety is paramount, so please adhere to these guidelines.

Side Effects

If your child experiences nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult a doctor. Additionally, if symptoms do not improve within 7 days, or if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition that requires medical attention.

Before using this medication, consult a doctor if your child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like that seen in asthma. Also, do not use this medication in children who are taking certain prescription drugs called monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping them. If you're unsure whether your child's medication includes an MAOI, please ask a doctor or pharmacist.

Warnings and Precautions

It's important to be cautious when giving this medication to your child. Do not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or if they have stopped taking an MAOI within the last two weeks. If you're unsure whether your child's medication 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: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like asthma. If your child experiences an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using the medication and call your doctor if your child becomes nervous, dizzy, or has trouble sleeping. Additionally, if symptoms do not improve within seven days, or if a cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious issue that needs medical attention.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

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, although specific studies or data are not provided. 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.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor 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, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to be cautious when giving medication to children. You should never use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks. Before using it, consult your doctor if your child has any heart issues, high blood pressure, thyroid problems, or diabetes.

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. This medication is not recommended for children under 4 years old. Always keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 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 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to be cautious when giving medications to children, especially if they are taking certain prescription drugs. Specifically, you should not use this medication in a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist for guidance.

Always discuss any medications or tests 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 room temperature between 20-25°C (68-77°F). It's important not to refrigerate it, as this can affect its effectiveness. Before use, check that the printed neckband is intact; do not use the product if it is broken or missing, as this could compromise safety.

When preparing to use the product, make sure to utilize the dosing cup provided for accurate measurement. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally and follow the dosing instructions carefully. It's important to keep it out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Make sure to measure your dose using only the provided dosing cup, and do not use this cup with any other products. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and consult your doctor, as these may indicate a more serious condition. Store the medication at room temperature, between 20-25°C (68-77°F), and do not refrigerate. Lastly, do not use the medication if the printed neckband is broken or missing.

FAQ

What is Children's Mucus Relief used for?

Children's Mucus Relief is used to relieve stuffy nose, chest congestion, and cough in children aged 4 to 12 years.

What are the active ingredients in Children's Mucus Relief?

It contains Guaifenesin (100 mg), Dextromethorphan HBr (5 mg), and Phenylephrine HCl (2.5 mg).

How should I dose Children's Mucus Relief?

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

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child gets nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days.

Are there any contraindications for using Children's Mucus Relief?

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

Is it safe to use Children's Mucus Relief during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use.

Can nursing mothers use Children's Mucus Relief?

Nursing mothers should consult a doctor before using this product, as it may be excreted in breast milk.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Children's Mucus Relief?

Store at 20-25°C (68-77°F) and do not refrigerate. Ensure the printed neckband is intact.

Packaging Info

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

Packaging configurations for Dg Health Childrens Mucus Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Guaifenesin, an expectorant, is present at a concentration of 100 mg per 4 FL OZ (118 mL) dosage form. Dextromethorphan HBr, a cough suppressant, is included at a dosage of 5 mg. Additionally, Phenylephrine HCl serves as a nasal decongestant at a concentration of 2.5 mg. The formulation is flavored with a mixed berry flavor to enhance palatability.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, aiding in the ability of children to sleep. It also alleviates nasal congestion and a stuffy nose associated with colds.

Limitations of use include its application solely for symptomatic relief and not as a treatment for underlying conditions.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative to measure the dosage using only the dosing cup provided with the product, and this cup should not be used for measuring other products.

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

Healthcare professionals should ensure that dosing instructions are followed precisely and that caregivers are informed about the importance of adhering to the specified dosing guidelines.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. 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, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product in pediatric patients.

Warnings This product must not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of 2 weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child’s prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Prior to use, it is advisable to consult a healthcare provider if the child has any of the following conditions:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • A cough that produces excessive phlegm (mucus)

  • A persistent or chronic cough, such as that associated with asthma

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Discontinuation and Consultation Parents or guardians should discontinue use and seek medical advice if the child experiences any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Symptoms that do not improve within 7 days or are accompanied by fever

  • A cough that persists beyond 7 days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients should be monitored for adverse reactions when using this product. Serious adverse reactions may necessitate discontinuation of use and consultation with a healthcare professional. Parents are advised to seek medical attention if their child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, a healthcare provider should be consulted. A cough that persists for more than 7 days, recurs, or occurs with fever, rash, or a persistent headache may indicate a serious underlying condition and requires medical evaluation.

Before administering this product, it is important to consult a healthcare provider if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or a cough associated with excessive phlegm. Furthermore, caution is advised in cases of persistent or chronic cough, such as that which occurs with asthma.

This product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in the child’s prescription medication, it is essential to consult a healthcare professional or pharmacist prior to use.

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, certain psychiatric conditions, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

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 recommended to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Dg Health Childrens Mucus Relief.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a history of heart disease, high blood pressure, thyroid disease, or diabetes.

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

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 prior to use. 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 before using this product during pregnancy to ensure the health and safety of both the patient and the fetus.

Lactation

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

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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to ensure effective management and to mitigate potential complications associated with the overdose.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs, including nervousness, dizziness, and sleeplessness. Additionally, symptoms that may indicate a serious condition have been noted. These include a cough that occurs with excessive phlegm, a persistent or chronic cough similar to that associated with asthma, and symptoms that do not improve within 7 days or occur alongside fever. Furthermore, a cough lasting more than 7 days, returning, or occurring with fever, rash, or persistent headache has also been documented.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if the child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, patients should be advised to seek medical advice. It is also important to inform patients that they should stop use and contact a doctor if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces excessive phlegm (mucus). Furthermore, patients should be advised to seek medical advice if the child has a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise in quality. Proper handling and storage conditions are crucial to maintain the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose. Patients are advised not to exceed the recommended dosage and to discontinue use and consult a doctor if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should measure the medication using only the dosing cup provided and should not use this cup with other products. Additionally, the medication should not be used if the printed neckband is broken or missing. Proper storage conditions include maintaining the product at 20-25°C (68-77°F) and avoiding refrigeration.

Drug Information (PDF)

This file contains official product information for Dg Health Childrens 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 Dg Health Childrens 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.

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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.