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Mucus Relief Cough Cold Sore Throat

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Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2023
Label revision date
April 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2023
Label revision date
April 8, 2024
Manufacturer
H E B
Registration number
M012
NDC root
37808-811
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 Cough, Cold & Sore Throat is a medication designed for children aged 6 to 11 years, formulated to temporarily relieve common cold and flu symptoms. It contains several active ingredients: acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant that helps loosen mucus), and phenylephrine HCl (a nasal decongestant). This combination works to alleviate symptoms such as cough, sore throat, nasal congestion, chest congestion, minor aches and pains, and headaches, while also helping to reduce fever.

The medication is available in a pleasant berry flavor and is intended to help your child feel more comfortable by easing coughing and congestion, allowing for better sleep and overall relief from cold symptoms.

Uses

This medication is designed to help you feel better when you're dealing with common cold and flu symptoms. It can temporarily relieve a variety of discomforts, including coughs caused by minor throat and bronchial irritation, nasal congestion, a stuffy nose, sore throat, minor aches and pains, and headaches. If your child is having trouble sleeping due to coughing, this medication can also help reduce the urge to cough.

In addition to easing these symptoms, it can temporarily lower fever and assist in loosening phlegm (mucus) and thinning bronchial secretions. This makes it easier to clear out mucus from your airways, leading to more productive coughs. Overall, this medication aims to provide relief and help you or your child feel more comfortable during illness.

Dosage and Administration

When using this product, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. For children aged 6 to under 12 years, you should measure out 10 mL using the dosing cup that comes with the product. Make sure to keep this dosing cup with the product and do not use any other measuring device, as this can lead to incorrect dosing.

You should not give more than 5 doses in a 24-hour period, and if symptoms persist, you can repeat the dose every 4 hours. However, do not continue this for more than 5 days unless a doctor has specifically directed you to do so. Remember, this product does not include complete directions or warnings for adult use, so it's essential to adhere strictly to the guidelines provided for children. Always consult a healthcare professional if you have any questions or concerns.

What to Avoid

You should avoid using this product if your child is taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure about a medication's ingredients, it's best to consult with a doctor or pharmacist. Additionally, do not give this product to a child who is currently on a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping such medication. Lastly, ensure that your child is not allergic to acetaminophen or any of the inactive ingredients in this product.

It's also important to follow the dosing instructions carefully and not exceed the recommended amount, as doing so can lead to serious health risks. If you have any questions or concerns, please reach out to a healthcare professional for guidance.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. Severe liver damage may occur if you give your child more than 5 doses in 24 hours or if they take it with other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which can include symptoms like skin reddening, blisters, or rashes. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if your child experiences severe sore throat that lasts more than 2 days, especially if accompanied by fever, headache, rash, nausea, or vomiting. Other signs to watch for include increased nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days. If new symptoms arise or if a fever worsens or lasts more than 3 days, it's important to seek medical advice. Remember, taking more than the recommended dose can lead to overdose and liver damage, so if you suspect an overdose, contact a medical professional or Poison Control Center right away.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. It contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Before using this product, check with a doctor if your child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough with excessive mucus, or breathing problems like chronic bronchitis. If your child is taking the blood thinner warfarin, consult a doctor or pharmacist before use. In case of an overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as quick attention is crucial.

You should also stop using the product and call your doctor if your child experiences nervousness, dizziness, or sleeplessness, if pain or cough worsens or lasts more than 5 days, if redness or swelling occurs, or if new symptoms develop. Additionally, if a fever worsens or lasts more than 3 days, or if a cough returns with a rash or headache, these could indicate a serious condition that requires medical attention.

Overdose

Taking more than the recommended dose of medication can lead to serious health issues, including liver damage. If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Even if you don’t notice any signs or symptoms, quick medical attention is crucial for both adults and children. Remember, acting fast can make a significant difference in the outcome.

Pregnancy Use

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

If you do decide to use it, make sure to do so only if it is clearly needed and after discussing it with a healthcare professional. There are no specific dosage modifications mentioned for pregnant individuals, so your healthcare provider can offer the best guidance tailored to your situation.

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, and the effects on your nursing infant are not fully understood. Therefore, caution is recommended when considering this product while nursing. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is between 6 and 12 years old, you can give them 10 mL of the medication using the dosing cup provided. However, it's important not to exceed 5 doses in a 24-hour period and to limit use to no more than 5 days unless a doctor advises otherwise. For children under 6 years old, this medication should not be used.

Before giving this medication, consult a doctor if your child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough with excessive mucus, or breathing issues like chronic bronchitis. Additionally, if your child is taking the blood thinner warfarin, it's essential to check with a doctor or pharmacist before use.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If your child has liver disease, it's important to consult a doctor before using this product, which contains acetaminophen. Be aware that taking more than 5 doses in a 24-hour period, or combining it with other medications that also contain acetaminophen, can lead to severe liver damage.

In case of an overdose—taking more than the recommended amount—liver damage may occur. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no immediate signs or symptoms.

Drug Interactions

It's important to be cautious when using this medication, especially if you or your child are taking other drugs. You should avoid using it alongside any other medications that contain acetaminophen, whether they are prescribed or available over-the-counter. Additionally, if your child is on a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain other conditions—this medication should not be used, and you should wait at least two weeks after stopping the MAOI before starting it.

Before using this medication, it's also wise to consult with a healthcare provider if your child is taking warfarin, a blood-thinning medication. Discussing all medications and health conditions with your doctor or pharmacist helps ensure safety and effectiveness in your treatment plan.

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 it. Always keep the dosing cup that comes with the product, as it is specifically designed for accurate dosing. Avoid using any other dosing devices to ensure safety and effectiveness.

Before using the product, check that the carton is sealed properly. Do not use it if the carton is opened or if the safety seal around the bottle or under the cap is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children. Before giving it to your child, consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough with excessive mucus, or breathing issues like chronic bronchitis or asthma. Additionally, if your child is taking the blood thinner warfarin, check with a doctor or pharmacist first.

If your child experiences nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or a cough that lasts more than five days, stop using the medication and consult a doctor. Also, seek medical advice if redness or swelling occurs, new symptoms develop, fever worsens or lasts more than three days, or if a cough returns with a rash or headache that persists.

FAQ

What is Children's Mucus Relief Cough, Cold & Sore Throat used for?

It temporarily relieves common cold and flu symptoms such as cough, sore throat, nasal congestion, and minor aches and pains.

What age group is this medication suitable for?

This product is intended for children aged 6 to 11 years.

What are the active ingredients in this medication?

It contains acetaminophen (325 mg), dextromethorphan HBr (10 mg), guaifenesin (200 mg), and phenylephrine HCl (5 mg).

How should I administer this medication to my child?

Use the enclosed dosing cup to give 10 mL to children aged 6 to under 12 years. Do not use in children under 6 years.

What should I do if my child experiences an overdose?

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

Are there any warnings associated with this medication?

Yes, severe liver damage may occur if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

Can this medication be used during pregnancy?

The safety of this product during pregnancy has not been established; consult a healthcare professional before use.

What should I do if my child has a severe sore throat?

If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

What are the potential side effects of this medication?

Possible side effects include severe skin reactions, nervousness, dizziness, and sleeplessness. Stop use and consult a doctor if these occur.

How should I store this medication?

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

Packaging Info

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

Packaging configurations for Mucus Relief Cough Cold Sore Throat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains Acetaminophen 325 mg, a pain reliever and fever reducer; Dextromethorphan HBr 10 mg, a cough suppressant; Guaifenesin 200 mg, an expectorant; and Phenylephrine HCl 5 mg, a nasal decongestant. The product is designed for children aged 6 to 11 years and provides relief from cough, sore throat, nasal congestion, and chest congestion. It features a berry flavor for palatability. The packaging is tamper-evident; do not use if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. This product is manufactured with pride and care for H-E-B® in San Antonio, TX 78204.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in pediatric patients. Specifically, it alleviates cough due to minor throat and bronchial irritation, reduces the intensity and impulse to cough, and assists in promoting sleep. Additionally, it addresses nasal congestion, stuffy nose, sore throat, minor aches and pains, and headache.

This medication also temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and making coughs more productive.

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

Dosage and Administration

This product is intended for use in children aged 6 years and older. The recommended dosage for children aged 6 to under 12 years is 10 mL, administered using the enclosed dosing cup specifically designed for this product. It is imperative that healthcare professionals instruct caregivers to utilize only the provided dosing cup and to keep it with the product at all times.

Dosing should not exceed 5 doses within a 24-hour period. If necessary, doses may be repeated every 4 hours while symptoms persist. Treatment should not extend beyond 5 days unless directed by a healthcare professional.

For children under 6 years of age, the use of this product is not recommended. Caregivers should be advised to adhere strictly to these guidelines to avoid the risk of overdose and ensure safe administration.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

This product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a child's medication regimen, a healthcare professional should be consulted.

Additionally, the product must not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

Finally, it is essential to adhere to the recommended dosage and not exceed the directed use, as outlined in the overdose warning.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise parents to consult a physician if their child experiences a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting.

Before administering this product, it is essential to inquire about the child's medical history. Consultation with a healthcare provider is recommended if the child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough associated with excessive phlegm, or any breathing problems such as chronic bronchitis or persistent cough related to asthma. Additionally, it is crucial to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is necessary. Parents should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Parents should be instructed to discontinue use and seek medical advice if their child experiences nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days; if redness or swelling occurs; if new symptoms develop; if fever worsens or lasts more than 3 days; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take acetaminophen concurrently with other medications containing acetaminophen. In cases of overdose, immediate medical assistance is crucial, and patients should contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients may experience severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, it is imperative to discontinue use and seek medical attention immediately.

In instances where patients present with a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Patients should also be instructed to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than five days; if redness or swelling occurs; if new symptoms develop; if fever worsens or persists beyond three days; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, the use of this medication is contraindicated in those who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this medication should not be administered for a period of 2 weeks following the discontinuation of an MAOI.

Caution is advised when considering the use of this medication in children who are taking the anticoagulant warfarin. It is recommended to consult a healthcare professional, such as a doctor or pharmacist, prior to use to assess potential interactions and the need for monitoring.

Packaging & NDC

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

Packaging configurations for Mucus Relief Cough Cold Sore Throat.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 10 mL using the dosing cup provided. For children under 6 years of age, the product is not recommended. It is important to limit administration to no more than 5 doses within a 24-hour period and to avoid use for more than 5 consecutive days unless directed by a healthcare professional.

Prior to use, caregivers should consult a doctor if the child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough associated with excessive phlegm, or a respiratory condition such as chronic bronchitis. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant medication warfarin.

Geriatric Use

There is no specific information available 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 provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; therefore, it is essential for healthcare professionals to provide guidance tailored to the individual patient's circumstances. This product should only be used if clearly needed and after thorough consultation with a healthcare professional to weigh the potential benefits against any risks.

Lactation

Nursing mothers should consult a doctor before using this product due to the potential for excretion in breast milk. The effects of this product on a nursing infant are not known, and caution is advised when administering this product to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Before administering this product, it is advisable to consult a healthcare professional if the patient has a history of liver disease. In cases of overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of liver damage.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as timely intervention can mitigate the risk of severe complications, even in the absence of noticeable signs or symptoms.

Healthcare providers should remain vigilant and ensure that patients and caregivers are aware of the importance of quick medical attention in overdose scenarios.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult a doctor or pharmacist.

It is important to caution against using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be advised to verify with a healthcare professional if they are unsure whether their child's prescription includes an MAOI.

Patients should also be made aware of the potential for allergic reactions; this product should not be used if the child is allergic to acetaminophen or any inactive ingredients contained within.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than five days; redness or swelling; new symptoms; fever worsening or lasting more than three days; or if a cough recurs or is accompanied by a rash or persistent headache.

While using this product, patients must be reminded not to exceed the directed dosage, as highlighted in the overdose warning. Additionally, healthcare providers should encourage patients to seek medical advice before use if the child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough with excessive phlegm, chronic bronchitis, or a persistent cough associated with asthma.

Storage and Handling

The product is supplied in a container that includes a dosing cup specifically designed for use with this formulation. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration.

To ensure proper dosing, only the enclosed dosing cup should be utilized; the use of any other dosing device is not recommended. Additionally, the product features a tamper-evident design. It should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Additional Clinical Information

Patients should be informed that the medication is administered orally. It is crucial to keep the medication out of reach of children. Clinicians should advise patients to consult a doctor before use if the patient has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough associated with excessive phlegm, or chronic breathing issues such as chronic bronchitis or asthma.

Additionally, patients taking the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist prior to use. Patients are also advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if pain, nasal congestion, or cough worsens or persists beyond five days, if redness or swelling occurs, if new symptoms arise, if fever worsens or lasts more than three days, or if a cough recurs with a rash or headache lasting longer than usual.

Drug Information (PDF)

This file contains official product information for Mucus Relief Cough Cold Sore Throat, 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 Cold Sore Throat, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

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.