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Childrens Mucus Relief Multi Symptom Cold

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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)
Marketed in the U.S.
Since 2014
Label revision date
July 2, 2024
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
Marketed in the U.S.
Since 2014
Label revision date
July 2, 2024
Manufacturer
Rite Aid Corporation
Registration number
M012
NDC root
11822-0839

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Drug Overview

Children’s Mucus Relief Multi-Symptom Cold is a medication designed for children ages 4 to 12 years to help alleviate symptoms associated with the common cold. It 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 that relieves nasal congestion and a stuffy nose.

This product temporarily relieves cough due to minor throat and bronchial irritation, reduces the intensity of coughing, and helps control the impulse to cough, making it easier for your child to sleep. Additionally, it helps clear mucus from the bronchial passageways, making coughs more productive. With a pleasant very berry flavor, it is also gluten-free and alcohol-free, ensuring a gentle option for your child's cold symptoms.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This makes it easier to clear out bothersome mucus from your airways, which can lead to more productive coughs.

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 reduce the intensity of your cough and the urge to cough, making it easier for your child to fall asleep. Additionally, it can relieve nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should not 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, the dosage varies by age. If your child is between 6 years and under 12 years, they should take 10 mL every 4 hours. For children aged 4 years to under 6 years, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, this medication should not be used. 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 use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are certain medications 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, please consult a doctor or pharmacist.

Always follow the dosage instructions carefully and do not use more than directed. Misusing or abusing this medication can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Your safety and your child's well-being are the top priority, 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 if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks, as this could lead to serious interactions. If you're unsure about your child's medications, it's best to 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 monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if they have stopped taking it within the last two weeks. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, talk to your doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces a lot of mucus. You should also seek medical help immediately if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222.

If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days or worsen with fever, it's important to stop using the medication and call your doctor. Additionally, 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 requires 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are 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. You should consult your doctor before using it, as there may be potential risks to your fetus, although these risks are not specifically detailed.

While there are no specific dosage modifications for pregnant individuals, it is strongly advised to discuss your situation with a healthcare provider before using this product. Taking these precautions can help ensure the best outcomes for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 taken one in the last 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

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

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 giving certain medications to children, especially if they are taking a prescription monoamine oxidase inhibitor (MAOI). MAOIs are specific drugs used to treat depression, psychiatric conditions, or Parkinson’s disease. You should not use this product in a child who is currently taking an MAOI or for at least two weeks after stopping it. If you're unsure whether your child's medication includes an MAOI, it's best to 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 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, which helps ensure accurate measurement. Always handle the product with care to maintain its integrity and safety.

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 not to exceed the recommended dose. You should stop using the medication and consult a doctor if you experience a cough with excessive mucus, a persistent cough (like one associated with asthma), or if your child feels nervous, dizzy, or has trouble sleeping. Additionally, if symptoms do not improve within 7 days, or if you have a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious issue. Always use the dosing cup provided and do not mix it with other products.

FAQ

What is CHILDREN’S MUCUS RELIEF MULTI-SYMPTOM COLD used for?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough and nasal congestion due to colds.

What are the active ingredients in this product?

The active ingredients are Dextromethorphan HBr (a cough suppressant), Guaifenesin (an expectorant), and Phenylephrine HCl (a nasal decongestant).

What is the recommended dosage for children?

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

Are there any warnings 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 your child has heart disease, high blood pressure, thyroid disease, or diabetes.

What should I do if my child experiences side effects?

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

Is this product safe for 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.

How should this product be stored?

Store at 20-25°C (68-77°F) and do not refrigerate. Keep out of reach of children.

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.

Packaging Info

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

Packaging configurations for Childrens Mucus Relief Multi Symptom Cold.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Mucus Relief Multi-Symptom Cold is formulated for children aged 4 to 12 years and contains the active ingredients dextromethorphan HBr, guaifenesin, and phenylephrine HCl. Dextromethorphan HBr serves as a cough suppressant, while guaifenesin acts as an expectorant, and phenylephrine HCl functions as a nasal decongestant. This product is designed to provide relief from multiple cold symptoms without causing drowsiness. It is presented in a 4 FL OZ (118 mL) liquid dosage form with a very berry flavor. The formulation is free from gluten and alcohol, ensuring suitability for a wider range of dietary needs.

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 mucus from the bronchial passageways and making coughs more productive.

The drug temporarily relieves the following symptoms:

  • Cough due to minor throat and bronchial irritation.

  • The intensity of coughing.

  • The impulse to cough, aiding in sleep for children.

  • Nasal congestion and stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is essential 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 dosing, the following guidelines should be adhered to, unless otherwise directed by a healthcare professional:

  • 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.

  • The product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that caregivers are aware of these dosing instructions to promote safe and effective use of the medication.

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, or 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.

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 Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 without delay.

Stop Taking and Call Your Doctor Instructions Parents or guardians should discontinue use and consult a healthcare provider 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 for more than 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 or guardians 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, it may indicate a more serious condition requiring medical evaluation. A cough that persists for more than 7 days, recurs, or occurs with fever, rash, or a persistent headache should also prompt immediate medical consultation.

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 if the cough is associated with excessive phlegm (mucus) or is persistent, as seen in conditions like 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 commonly 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 doctor 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 medication contains an MAOI prior to the administration of this product. If there is any uncertainty, consultation with a physician or pharmacist is recommended to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Childrens Mucus Relief Multi Symptom Cold.
Details

Pediatric Use

Pediatric patients aged 4 to 12 years may use this medication, with specific dosing guidelines based on age. Children aged 6 years to under 12 years should receive 10 mL every 4 hours, while those aged 4 years to under 6 years should receive 5 mL every 4 hours. The medication is not recommended for children under 4 years of age.

Healthcare professionals should advise caregivers to consult a doctor before administering this medication if the child has a history of heart disease, high blood pressure, thyroid disease, or diabetes. Additionally, this medication must not be used in any child currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI.

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

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 provider prior to use. While potential risks to the fetus are not specified, caution is advised. There are no specific dosage modifications for pregnant individuals. It is recommended that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure appropriate management of therapy in these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness.

Additionally, symptoms that may indicate a serious condition have been noted. These symptoms include a cough that occurs with excessive phlegm (mucus), 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 reported.

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 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 their child experiences nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if symptoms do not improve within seven days or if they are accompanied by fever. It is important to inform patients that they should also 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 their child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm (mucus), or 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 product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are advised not to exceed the recommended dosage and to discontinue use while consulting a doctor if they experience a cough accompanied by excessive phlegm, a persistent or chronic cough (such as that associated with asthma), or if their child exhibits nervousness, dizziness, or sleeplessness. Additionally, patients should seek medical advice if symptoms do not improve within 7 days, or if the cough persists beyond 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

It is important for patients to measure the dosage using the provided dosing cup and to refrain from using this cup with other products. Dosing should be as directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Childrens Mucus Relief Multi Symptom Cold, 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 Childrens Mucus Relief Multi Symptom Cold, 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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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.