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Mucus Relief Cough and Congestion

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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 2022
Label revision date
October 4, 2024
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 2022
Label revision date
October 4, 2024
Manufacturer
KinderFarms, LLC
Registration number
M012
NDC root
82673-102
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

KIDS' COUGH & CONGESTION is a medication designed for children aged 4 to 11 years to help relieve cough and congestion associated with minor throat and bronchial irritation, often caused by the common cold or inhaled irritants. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to reduce the urge to cough, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

This medication temporarily alleviates coughing, allowing children to rest more comfortably, especially at night. With its organic berry flavor and absence of dyes and artificial sweeteners, it aims to provide a pleasant experience for young users while addressing their symptoms effectively.

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.

It can temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with common colds or when you inhale irritants. Additionally, it can reduce the intensity of your cough and help lessen the urge to cough, making it easier for your child to fall asleep.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. First, make sure to shake the bottle well before each use. You should only measure the medication using the dosing cup that comes with the product; using any other device could lead to incorrect dosing. Keep the dosing cup with the product to avoid any mix-ups.

For children aged 6 to under 12 years, the recommended dose is between 5 to 10 milliliters (mL) every 4 hours, but remember not to exceed 6 doses in a 24-hour period. For younger children aged 4 to under 6 years, the dose is 2.5 to 5 mL every 4 hours. It's crucial to note that this medication should not be used for children under 4 years of age. Always adhere to these guidelines to ensure the best care for your child.

What to Avoid

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific drugs used to treat depression, certain psychiatric or emotional 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, it's important to consult with a doctor or pharmacist before proceeding with this product.

Be mindful that misuse or abuse of this medication can lead to dependence (a condition where the body becomes reliant on a substance). Always follow these guidelines to ensure safety and effectiveness.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not use it if your child is taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

Before using this product, talk to a doctor if your child has a cough with excessive mucus or a persistent cough, such as one associated with asthma. If the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a lasting headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. In case of an overdose, it's crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 a cough that produces a lot of mucus or a persistent cough, such as one associated with asthma. If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or headache that persists, stop using the medication and contact a doctor, as these may indicate a more serious issue. In the event of an overdose, seek immediate medical assistance or call a Poison Control Center at 1-800-222-1222.

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 safety is the top priority.

Pregnancy Use

There is currently no specific information available about the use of MUCUS RELIEF COUGH AND CONGESTION CHILDREN'S (which contains dextromethorphan hbr and guaifenesin) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions for pregnant individuals have not been addressed in the provided drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication. They can help you understand any potential risks and guide you on the best options for managing your symptoms safely.

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. If your child is taking a prescription monoamine oxidase inhibitor (MAOI), do not use this medication, and wait at least two weeks after stopping the MAOI before considering it. Always consult a doctor if your child has a cough with excessive mucus or a persistent cough, such as one associated with asthma. If the cough lasts more than seven days, returns, or is accompanied by a fever, rash, or headache, stop using the medication and seek medical advice.

For dosing, children aged 6 to under 12 years can take 5-10 mL every four hours, while those aged 4 to under 6 years should take 2.5-5 mL every four hours. This medication is not recommended for children under 4 years old. Always keep medications out of reach of children, and in case of an overdose, contact a medical professional or the Poison Control Center immediately at 1-800-222-1222.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your doctor. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any age-related health considerations, as older adults may experience different effects from medications compared to younger individuals.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 situation. They can help determine the best course of action based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

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 your treatment is safe and effective based on your individual health needs.

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 product in a child who is taking an MAOI or for at least two weeks after stopping it. If you're unsure whether your child's medication includes an MAOI, please consult with a healthcare provider 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 results with your product, store it at room temperature, specifically between 20-25ºC (68-77ºF). It's important not to refrigerate the product, as this can affect its effectiveness. Always keep the dosing cup with the product for accurate measurement. Before using, make sure to shake the bottle well to mix the contents properly.

For your safety, check that the bottle is tamper evident, meaning it has a safety seal with a perforated band around it. If the seal is disturbed or missing, do not use the product. Following these guidelines 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 KIDS' COUGH & CONGESTION used for?

KIDS' COUGH & CONGESTION helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough due to minor throat and bronchial irritation.

What are the active ingredients in KIDS' COUGH & CONGESTION?

The active ingredients are Dextromethorphan HBr (5 mg per 5 mL), a cough suppressant, and Guaifenesin (100 mg per 5 mL), an expectorant.

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

Children aged 6 to under 12 years should take 5-10 mL every 4 hours.

What should I do if my child is taking a monoamine oxidase inhibitor (MAOI)?

Do not use KIDS' COUGH & CONGESTION in a child who is taking an MAOI or for 2 weeks after stopping the MAOI. Consult a doctor or pharmacist if unsure.

What precautions should I take before using this product?

Ask a doctor before use if your child has a cough with too much phlegm or a persistent cough, such as with asthma.

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 headache.

Is KIDS' COUGH & CONGESTION safe to use during pregnancy?

There is no specific information regarding the safety of KIDS' COUGH & CONGESTION during pregnancy. Consult a doctor for advice.

Can nursing mothers use KIDS' COUGH & CONGESTION?

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

How should I store KIDS' COUGH & CONGESTION?

Store the product between 20-25ºC (68-77ºF) and do not refrigerate. Keep the dosing cup with the product.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Mucus Relief Cough and Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

KIDS' COUGH & CONGESTION is formulated for children aged 4 to 11 years and contains Dextromethorphan HBr at a concentration of 5 mg per 5 mL, serving as a cough suppressant. Additionally, it includes Guaifenesin at 100 mg per 5 mL, functioning as an expectorant. The product features an organic berry flavor and is free from dyes, artificial flavors, and artificial sweeteners. A dosage cup is provided for accurate measurement. The product is packaged in a tamper-evident bottle that is safety sealed with a perforated band; it should not be used if the bottle seal is disturbed or missing. For complete warnings and product information, the outer carton should be retained. This product is distributed by KinderFarms®, located in Redondo Beach, CA 90277, and further information can be found at kinderfarms.com.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may help children achieve restful sleep.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

Before administration, the product must be shaken well. The dosing cup provided with the product should be used exclusively for measuring doses; no other dosing devices should be utilized. It is essential to keep the dosing cup with the product at all times.

For children aged 6 to under 12 years, the recommended dosage is 5 to 10 mL every 4 hours, with a maximum of 6 doses within a 24-hour period. For children aged 4 to under 6 years, the dosage is 2.5 to 5 mL every 4 hours, also not exceeding 6 doses in a 24-hour period. The product is not recommended for use in children under 4 years of age.

It is critical to ensure that the total daily dosage does not exceed the specified limits to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, consultation with a healthcare professional, such as a doctor or pharmacist, is advised prior to use.

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 should not be administered for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise caregivers 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 presents with a cough accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in conditions such as asthma.

Caregivers should be instructed to discontinue use and seek medical advice if the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

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

Serious adverse reactions may occur in patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is crucial to avoid using this product in such cases, as it may lead to significant health risks. Patients are advised to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their child's prescription medication.

Common adverse reactions include the need to seek medical advice before use if the child has a cough accompanied by excessive phlegm or a persistent cough, such as that which occurs with asthma.

Patients should discontinue use and consult a healthcare professional if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

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 or emotional conditions, and Parkinson's disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has discontinued an MAOI within the past two weeks.

Healthcare providers should ensure that patients or caregivers are aware of the potential presence of MAOIs in any prescription medications. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to the use of this product.

Packaging & NDC

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

Packaging configurations for Mucus Relief Cough and Congestion.
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 cough accompanied by excessive phlegm or a persistent cough, such as that associated with asthma.

If the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts, the use of this medication should be discontinued, and a doctor should be consulted.

Dosing recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the dosage is 5-10 mL every 4 hours; for children aged 4 to under 6 years, the dosage is 2.5-5 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 drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of polypharmacy and the presence of comorbid conditions in geriatric patients, which may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

There is no specific information available regarding the use of MUCUS RELIEF COUGH AND CONGESTION CHILDRENS (dextromethorphan hbr, guaifenesin liquid) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for women of childbearing potential. It is advisable to consult with a healthcare provider for individualized recommendations.

Lactation

Nursing 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 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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

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 question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and swelling. Additional reported events encompass dizziness, drowsiness, nausea, vomiting, and gastrointestinal disturbances. Cardiovascular effects such as increased heart rate have also been noted.

Neuropsychiatric events, including hallucinations, confusion, and agitation, have been documented. Furthermore, seizures and respiratory depression have been reported as serious adverse events. Other serious adverse events have been noted; however, the frequency and causal relationship to the drug remain unestablished.

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 medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a lasting headache, as these symptoms may indicate a serious condition.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if the child has a cough associated with excessive phlegm (mucus) or if the child experiences a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well to ensure proper consistency.

The bottle is designed with a tamper-evident feature, which includes a safety seal with a perforated band around the bottle. Users should not utilize the product if the bottle seal is disturbed or missing, as this may indicate potential tampering.

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 Cough and Congestion, 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 Cough and Congestion, 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.