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Respiratory 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 2025
Label revision date
July 29, 2025
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 2025
Label revision date
July 29, 2025
Manufacturer
Schwabe North America, Inc
Registration number
M012
NDC root
53499-5295
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 you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

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 while your symptoms last. It's important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 tablets in a 24-hour period to avoid any potential side effects.

If your child is under 12 years old, please do not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

If you are using this medication, it's important to know when to stop. You should stop using it and consult your doctor if your cough lasts more than 7 days, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache. These signs may indicate a more serious condition that needs medical attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns about abuse or dependence associated with this medication. Always prioritize your health and seek guidance from a healthcare professional if you have any questions or concerns.

Side Effects

If you are considering using this medication, please be aware that it is not recommended for children under 12 years of age. You should stop using it and consult a doctor if your cough lasts more than 7 days, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, as these could indicate a more serious condition.

Additionally, it's important to talk to your doctor before using this medication if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, especially if your cough produces a lot of mucus.

Warnings and Precautions

You should not use this medication if you are under 12 years of age. If you have a cough that lasts more than 7 days, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, stop taking the medication and contact your doctor. A persistent cough could indicate a more serious health issue.

Before using this medication, it’s important to consult your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, especially if your cough comes with a lot of mucus. Always prioritize your health and seek medical advice when needed.

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 professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your 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

It is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

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 for personalized advice. 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 your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle 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, but do not exceed 6 tablets in a 24-hour period. If your child is under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and aiding in ridding the bronchial passageways of bothersome mucus.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 tablets in 24 hours.

Can children under 12 years of age use this drug?

No, this drug should not be used for children under 12 years of age.

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

You should stop use and ask a doctor if your cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Are there any warnings for using this drug?

Yes, do not use this drug for children under 12 years of age, and consult a doctor if you have a persistent or chronic cough, especially if it is accompanied by excessive phlegm (mucus).

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a healthcare professional before using this drug.

How should I store this drug?

Store the drug at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed. Discard after opening.

Are there any known drug interactions?

No drug interactions were mentioned in the provided text.

What should I do if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and you should monitor renal function tests regularly.

Packaging Info

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

Packaging configurations for Respiratory Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential to administer the tablet with a full glass of water. The maximum dosage should not exceed 6 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. In such cases, it is advised to discontinue use and consult a healthcare professional.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Prior to initiating treatment, it is essential to consult a healthcare provider if the patient has a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, caution is warranted for patients experiencing a cough accompanied by excessive phlegm (mucus), as this may necessitate further investigation.

Monitoring for these symptoms and conditions is crucial to ensure the safe use of this medication and to mitigate potential risks associated with its use.

Side Effects

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

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

Stop Use Patients are advised to discontinue use and consult a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Ask a Doctor Before using this medication, patients should seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Respiratory Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children under 12 years.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

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

Renal Impairment

Patients with renal impairment may require dosage adjustments due to reduced renal function. It is essential to monitor renal function tests regularly in patients with known kidney problems to ensure safety and efficacy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered. Additionally, special monitoring is necessary for patients with severe renal impairment to manage potential risks effectively.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

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 aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement these measures swiftly to ensure optimal patient outcomes in cases of overdose.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their cough lasts more than 7 days, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache. It is important to inform patients that a persistent cough may indicate a serious underlying condition that requires medical evaluation.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus). This precaution helps ensure that patients receive appropriate care and management for their symptoms.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. It is important to note that the product should be discarded after opening to maintain safety and efficacy.

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, not to exceed six tablets within a 24-hour period. It is advised that children under 12 years of age should not use this medication.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Respiratory 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 Respiratory 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.