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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 2004
Label revision date
December 2, 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 2004
Label revision date
December 2, 2024
Manufacturer
Geri-Care Pharmaceuticals, Corp
Registration number
M012
NDC root
57896-794
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear out bothersome mucus from your bronchial passageways. 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 (a type of mucus) and thinning out bronchial secretions. When you have a cough, this can make it more productive, allowing you to clear out bothersome mucus from your bronchial passageways. By doing so, it can help relieve discomfort and improve your overall breathing.

Dosage and Administration

When taking this medication, make sure to swallow it with a full glass of water. It's important to follow the recommended dosage and not exceed it to ensure your safety and effectiveness of the treatment.

For adults and children aged 12 years and older, you should take 1 tablet every 4 hours as long as your symptoms continue. However, remember that you should not take more than 6 doses within a 24-hour period. If you have children under 12 years of age, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

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

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a more serious condition. If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and contact your doctor, as these symptoms may indicate a more serious condition.

If you are pregnant or breastfeeding, please seek advice from a healthcare professional before using this product. In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

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

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every four hours as needed for symptoms, but be careful not to exceed six doses in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as 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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you might be using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the safety seal under the cap is intact before use. If the seal is broken or missing, do not use the product.

For proper storage, keep the product in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F - 86°F), but try to maintain the ideal conditions as much as possible. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 and older, the recommended dose is 1 tablet every 4 hours as needed for symptoms, but do not exceed 6 doses in a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them. There are no additional details 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 to clear bothersome mucus from the bronchial passageways.

How should I take this medication?

You should take this medication with a full glass of water. Adults and children 12 years and over can take 1 tablet every 4 hours while symptoms persist, but do not exceed 6 doses in 24 hours.

Can children use this medication?

No, this medication should not be used by children under 12 years of age.

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

You should stop using the medication and ask a doctor if your cough lasts more than 7 days or comes back, or if it occurs with fever, rash, or persistent headache.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this medication.

Are there any warnings I should be aware of?

Yes, ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by excessive phlegm. Get emergency medical help in case of overdose.

How should I store this medication?

Store the medication at 20°-25°C (68°-77°F), with excursions permitted between 15°C-30°C (59°F - 86°F).

What should I do if the safety seal is broken or missing?

Do not use the medication if the imprinted safety seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Mucus Relief.
Details

Drug Information (PDF)

This file contains official product information for 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 additional 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, thereby facilitating more productive coughs. This action aids in clearing the bronchial passageways of bothersome mucus, improving respiratory function and comfort.

Dosage and Administration

Patients should take the medication with a full glass of water. It is imperative not to exceed the recommended dose.

For adults and children aged 12 years and over, the recommended dosage is 1 tablet every 4 hours as needed while symptoms persist. The maximum allowable dosage is 6 tablets within a 24-hour period.

This medication is not recommended for use in children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days or if it recurs. Furthermore, if the cough is accompanied by fever, rash, or a persistent headache, it is imperative to seek medical attention, as these symptoms may indicate a serious underlying condition.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

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

Healthcare providers should remain vigilant and encourage patients to report any concerning symptoms or prolonged coughs, as timely intervention may be necessary.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is advised that patients consult a healthcare professional before use if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice prior to use.

Patients are instructed to discontinue use and consult a healthcare provider if their cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying illness.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a healthcare professional before using this medication to ensure safety for both the patient and the child.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Mucus Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed while symptoms persist, with a maximum of 6 doses in a 24-hour period. Caution is advised to ensure that the dosage does not exceed the recommended limits.

Geriatric Use

There is no specific information 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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

There is no specific information available 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 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 have not been defined.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that includes an imprinted safety seal under the cap. It is imperative that the product is not used if this seal is broken or missing, as this may compromise the integrity of the product.

For optimal storage, the product should be maintained at a temperature range of 20°-25°C (68°-77°F). Temporary excursions are permissible between 15°C-30°C (59°F - 86°F). Proper handling and storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a maximum of six doses within a 24-hour period. It is contraindicated for use in children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.