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Childrens Cough Mucus Relief

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 29, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2016
Label revision date
December 29, 2023
Manufacturer
Discount Drug Mart
Registration number
M012
NDC root
53943-512
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 Cough Mucus Relief is a medication designed for children ages 4 to 12 that helps alleviate cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve cough caused by minor throat and bronchial irritation, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain the bronchial tubes.

This alcohol-free syrup has a pleasant cherry flavor, making it more appealing for children. By relieving cough and helping to clear mucus, Children's Cough Mucus Relief can provide comfort during a cold.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially during a cold, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to clear out mucus from your airways. This can be particularly helpful if you're feeling congested or have difficulty breathing due to mucus buildup.

Dosage and Administration

It's important to follow the correct dosage when using this medication to ensure safety and effectiveness. For children aged 6 to 12 years, you can give them 1 to 2 teaspoonfuls (tsps) every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. If your child is between 4 and under 6 years old, the recommended dosage is 1/2 to 1 teaspoonful (tsps) every 4 hours, again ensuring that the total does not go over 6 doses in a day.

For children under 4 years old, this medication should not be used. Always keep track of how many doses your child has taken within a 24-hour period to avoid giving too much. If you have any questions or concerns about the dosage, consult with a healthcare professional for guidance.

What to Avoid

It's important to follow the instructions provided with your medication carefully. You should not use more than the directed amount, as taking more than recommended can lead to unwanted effects. Always adhere to the prescribed dosage to ensure your safety and the effectiveness of the treatment.

If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for guidance. Your health and well-being are the top priority.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If your child is taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, do not use this product. It's also crucial to wait at least two weeks after stopping an MAOI before using this medication.

If your child's cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these could indicate a more serious issue. Additionally, consult a doctor before use if your child has a cough with excessive mucus or a chronic cough, such as one associated with asthma.

Warnings and Precautions

You should not use this medication in a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, do not give this product for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

If your child experiences an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately. You should also stop using this medication and call your doctor if a cough lasts more than seven days, returns, or occurs alongside fever, rash, or a persistent headache, as these symptoms may indicate a more serious health issue.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this medication, as its safety during pregnancy has not been established. There may be potential risks to your fetus that are not clearly defined, so caution is advised.

You should only use this medication if it is clearly needed and after discussing it with your healthcare provider. There are no specific dosage modifications provided for pregnant individuals, but your doctor can help determine the best course of action for your situation.

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 if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the last two weeks. Before using the product, consult a doctor if your child has a cough with a lot of mucus or a persistent cough, such as one caused by asthma.

Make sure to follow the dosing guidelines carefully: for children aged 6 to 12 years, the recommended dose is 1 to 2 teaspoonfuls every 4 hours; for those aged 4 to under 6 years, it's 1/2 to 1 teaspoonful every 4 hours. Do not use this medication for children under 4 years old. Always stop use and consult a doctor if the cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache. Remember to use the medication only as directed.

Geriatric Use

When considering Children's Cough Mucus Relief (dextromethorphan HBr, guaifenesin liquid) for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means that there may not be established guidelines or dosage recommendations tailored for older adults.

If you are caring for an older adult, it's essential to consult with a healthcare professional before using this medication. They can help determine if it's appropriate based on individual health needs and any other medications being taken. Always prioritize safety and ensure that any treatment plan is suitable for the unique considerations of older adults.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be cautious when giving this medication to children, especially if they are taking certain prescription drugs known as monoamine oxidase inhibitors (MAOIs). These are medications often used for depression, psychiatric conditions, or Parkinson's disease. You should not use this medication 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 prescription includes an MAOI, please consult with a doctor or pharmacist before administering this product.

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

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness. You will find a dosing cup included with your product, which is designed to help you measure the correct amount for use. Be sure to keep the carton, as it contains important directions for how to use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Children's Cough Mucus Relief?

Children's Cough Mucus Relief is a cough suppressant and expectorant that is alcohol-free and designed for children ages 4 to 12.

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

The active ingredients are Dextromethorphan HBr (5 mg) and Guaifenesin (100 mg).

How does Children's Cough Mucus Relief work?

It temporarily relieves cough due to minor throat and bronchial irritation and helps loosen phlegm (mucus) to drain the bronchial tubes.

What is the recommended dosage for children aged 6 to 12?

Children aged 6 to 12 should take 1 to 2 teaspoonfuls (tsps) every 4 hours, not exceeding 6 doses in 24 hours.

Can children under 4 years use this product?

No, do not use Children's Cough Mucus Relief in children under 4 years.

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

Stop use and ask a doctor if the cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Are there any contraindications for using this product?

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

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

Safety during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

How should I store Children's Cough Mucus Relief?

Store the product between 20-25°C (68-77°F) and do not refrigerate.

What flavor does Children's Cough Mucus Relief come in?

It comes in a cherry flavor.

Packaging Info

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

Packaging configurations for Childrens Cough Mucus Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Cough Mucus Relief is a cough suppressant and expectorant formulation designed for pediatric use in children aged 4 to 12 years. Each 4 FL OZ (118 ml) dose contains 5 mg of Dextromethorphan HBr and 100 mg of Guaifenesin. This combination effectively relieves chest congestion by thinning and loosening mucus. The product is alcohol-free and is presented in a cherry flavor for palatability.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period.

For children aged 6 years to 12 years, the recommended dosage is 1 to 2 teaspoonfuls (tsps) administered every 4 hours as needed.

For children aged 4 years to under 6 years, the dosage is 1/2 to 1 teaspoonful (tsps) every 4 hours as required.

This medication is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that the dosing intervals are adhered to and that the total daily dosage does not exceed the specified limit.

Contraindications

There are no specified contraindications for the use of this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in 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 is advised that this product not be administered for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should ensure that caregivers are aware of this contraindication and encourage them to consult a physician or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

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

Healthcare providers should instruct patients or caregivers to discontinue use and seek medical advice if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in children who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks. It is crucial to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Common adverse reactions may include a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients are advised to discontinue use and seek medical advice if they experience such symptoms.

Additionally, it is recommended to consult a healthcare provider before using this product if the child has a cough associated with excessive phlegm or if the cough is persistent or chronic, as seen in conditions such as asthma.

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, 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 strongly recommended to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Childrens Cough Mucus Relief.
Details

Pediatric Use

Pediatric patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm (mucus) or a persistent cough, such as that associated with asthma.

Dosing recommendations for this product are as follows: for children aged 6 years to 12 years, the recommended dose is 1 to 2 teaspoonfuls (tsps) every 4 hours; for children aged 4 years to under 6 years, the recommended dose is 1/2 to 1 teaspoonful (tsps) every 4 hours. This product is not recommended for children under 4 years of age.

It is important to adhere strictly to the directed dosage. Parents and caregivers should discontinue use and consult a healthcare professional if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

Geriatric Use

There is no specific information regarding the use of Children's Cough Mucus Relief (dextromethorphan HBr, guaifenesin liquid) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Due to the lack of clinical data in this population, it is advisable to monitor geriatric patients closely for any adverse effects or changes in therapeutic response. Additionally, consideration should be given to potential age-related physiological changes that may affect drug metabolism and clearance.

As there are no established dosage adjustments or specific safety considerations outlined for elderly patients, healthcare providers should evaluate the individual needs and health status of geriatric patients before initiating treatment.

Pregnancy

Safety during pregnancy has not been established for this medication. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. The potential risks to the fetus are not clearly defined, and caution is advised when considering treatment. There are no specific dosage modifications recommended for pregnant individuals. It is essential to use this medication only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage when using this product. Additionally, healthcare providers should encourage patients to consult a doctor before use if the child has a cough that produces excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied with a dosing cup included in the packaging. It should be stored at a temperature range of 20-25°C (68-77°F) and must not be refrigerated. It is recommended to keep the carton for complete directions for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Cough 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 Childrens Cough 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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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.