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Quality Choice Mucus Relief

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
December 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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 2012
Label revision date
December 18, 2024
Manufacturer
Chain Drug Marketing Association
Registration number
M012
NDC root
63868-998
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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to expel bothersome mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways.

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed for relief. For children between the ages of 6 and 10, the recommended dose is 1/2 tablet every 4 hours, also as needed. However, if your child is under 6 years old, it’s important to consult a doctor before giving them this medication.

Make sure not to exceed 6 doses in a 24-hour period, unless your doctor has given you different instructions. This helps ensure that you use the medication safely and effectively. Always follow the guidance provided by your healthcare professional.

What to Avoid

It's important to use this medication safely. Always keep it out of reach of children to prevent accidental ingestion. If you experience symptoms like fever, rash, or a persistent headache while using this medication, stop taking it and consult your doctor. Additionally, if your cough lasts more than a week or keeps coming back, you should also stop using the medication and seek medical advice.

By following these guidelines, you can help ensure your safety and well-being while using this product.

Side Effects

If you are considering using this medication, it's important to consult your doctor first if you have a persistent or chronic cough, especially if it’s related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive mucus, you should also seek medical advice.

You should stop using the medication and contact your doctor if you experience symptoms like fever, rash, or a persistent headache. If your cough lasts more than a week or keeps coming back, it may indicate a more serious health issue that needs attention.

Warnings and Precautions

Before using this medication, it's important to talk to your doctor if you have a long-lasting cough due to smoking, asthma, bronchitis, or emphysema, especially if your cough comes with a lot of mucus.

Keep this medication out of reach of children. If you think you or someone else has taken too much, seek medical help or contact a Poison Control Center right away. You should stop using the medication and call your doctor if you experience a fever, rash, or a persistent headache, or if your cough lasts more than a week or keeps coming back, as this could indicate a more serious health issue.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local poison control center for guidance. If you experience severe symptoms, such as trouble breathing or loss of consciousness, call emergency services immediately. Always prioritize your safety and well-being.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving this medication to children, it's important to follow specific guidelines based on their age. For children aged 12 and older, you can administer 1 tablet every 4 hours as needed. For those between 6 and 10 years old, the recommended dose is 1/2 tablet every 4 hours. If your child is under 6 years old, you should consult a doctor before giving them this medication.

Always remember not to exceed 6 doses in a 24-hour period unless directed by a doctor. Additionally, keep the medication out of reach of children to ensure their safety.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep your doctor informed about any other medications or health conditions, as this can help ensure safe and effective treatment.

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 treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver 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 change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°-30°C (59°-86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You can take this medication as follows: Adults and children aged 12 and older should take 1 tablet every 4 hours as needed. For children aged 6 to 10, the recommended dose is 1/2 tablet every 4 hours as needed. If your child is under 6 years old, it's important to consult a doctor before giving them this medication. Remember not to exceed 6 doses in a 24-hour period unless directed by a doctor.

There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years of age and over should take 1 tablet every 4 hours as needed, not exceeding 6 doses in a 24-hour period.

What is the dosage for children aged 6 to 10?

Children aged 6 to 10 should take 1/2 tablet every 4 hours as needed, also not exceeding 6 doses in a 24-hour period.

What should I do if my child is under 6 years old?

Consult a doctor before giving this drug to children under 6 years of age.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I experience a persistent cough?

Stop use and ask your doctor if your cough persists for more than 1 week or tends to recur, as it may indicate a serious condition.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

What are the storage conditions for this drug?

Store the drug at 15°-30°C (59°-86°F).

Are there any known drug interactions?

No drug interactions are mentioned in the provided information.

Packaging Info

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

Packaging configurations for Quality Choice Mucus Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication aids in making coughs more productive, thereby improving respiratory function.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses in a 24-hour period, unless otherwise directed by a physician. Proper adherence to these guidelines is crucial for safe and effective use of the medication.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children.

Patients should discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. It is imperative to advise patients to consult their physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, bronchitis, or emphysema. Additionally, patients should be informed that the presence of excessive phlegm (mucus) accompanying the cough warrants medical consultation.

To ensure safety, this medication must be kept 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 without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience symptoms such as fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is crucial to seek medical advice, as a persistent cough may indicate a serious underlying condition.

In cases of overdose, it is essential to obtain emergency medical help or contact a Poison Control Center immediately to mitigate potential risks.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Patients are instructed to discontinue use and consult a healthcare provider if symptoms are accompanied by fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, warranting further evaluation.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Quality Choice Mucus Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet every 4 hours as needed, with a maximum of 6 doses in a 24-hour period or as directed by a physician. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed, also adhering to the maximum dosage limit.

For children under 6 years of age, consultation with a healthcare provider is advised prior to administration. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication 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 stop using the medication and consult their doctor if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, patients should be encouraged to seek medical advice, as a persistent cough may indicate a serious underlying condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours as needed, while children aged 6 to 10 years should take 1/2 tablet every 4 hours as needed. For children under 6 years of age, consultation with a doctor is recommended. It is important for patients to not exceed 6 doses within a 24-hour period unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Quality Choice 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 Quality Choice 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.

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.