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Guaifenesin

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Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
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
December 12, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
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
December 12, 2023
Manufacturer
BluePoint Laboratories
Registration number
ANDA210453
NDC root
68001-561
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

Guaifenesin Extended-Release Tablets 600 mg are a type of expectorant, which means they help relieve chest congestion. These tablets work by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear your airways and have more productive coughs.

Each tablet is designed to provide relief for up to 12 hours, helping you manage bothersome mucus and improve your breathing comfort throughout the day.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes it easier to clear out bothersome mucus from your airways, which can lead to more productive coughs.

In addition to helping with mucus, this medication also provides relief from chest congestion, allowing you to feel more comfortable. If you're dealing with thick mucus or congestion, this treatment can be a helpful option to consider.

Dosage and Administration

When taking this medication, it's important to swallow the tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 years and older, the recommended dose is 1 or 2 tablets every 12 hours. However, be careful not to exceed 4 tablets in 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

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than 7 days, returns, or occurs alongside symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any questions or concerns.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it’s important to stop using the medication and consult a doctor, as these symptoms could indicate a more serious condition.

Before using this medication, talk to your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus.

Warnings and Precautions

It's important to know that this medication should not be used for children under 12 years of age. If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop taking this medication and call your doctor if your cough lasts more than 7 days, returns, or occurs alongside symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

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 if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

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

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 is at least 12 years old 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 considering this medication, it’s important to consult with a healthcare provider. 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 and what steps to take for your safety.

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 you are taking or any lab tests you may undergo. In this case, there are no specific drug interactions or laboratory test interactions noted, which is a positive sign. However, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°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 should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, but do not exceed 4 tablets in a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them. Always follow the dosage instructions to ensure safe and effective use.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin Extended-Release Tablets help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

How should I take Guaifenesin Extended-Release Tablets?

You should take 1 or 2 tablets every 12 hours with a full glass of water, and do not exceed 4 tablets in 24 hours. Do not crush, chew, or break the tablet.

Who should not use Guaifenesin Extended-Release Tablets?

Do not use this medication for children under 12 years of age.

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

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, as these could be signs of a serious illness.

Are there any teratogenic effects associated with Guaifenesin?

No teratogenic effects are mentioned for Guaifenesin Extended-Release Tablets.

What should I do in case of an overdose?

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

Can I take Guaifenesin Extended-Release Tablets if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Guaifenesin Extended-Release Tablets.

What is the storage requirement for Guaifenesin Extended-Release Tablets?

Store Guaifenesin Extended-Release Tablets between 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Guaifenesin Extended-Release Tablets contain 600 mg of guaifenesin, an expectorant formulated to relieve chest congestion by thinning and loosening mucus. Each tablet is designed for extended-release over a 12-hour period, providing sustained relief. The product is supplied in a bottle containing 80 extended-release tablets.

Uses and Indications

This drug is indicated for the relief of chest congestion and the facilitation of productive coughs by loosening phlegm (mucus) and thinning bronchial secretions. It aids in clearing the bronchial passageways of bothersome mucus, thereby enhancing respiratory function.

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

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to administration. This product can be taken without regard for the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours. The total daily dosage should not exceed 4 tablets within a 24-hour period.

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

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. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Patients should not use this medication in children under 12 years of age due to safety concerns.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients are instructed to discontinue use and consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and management.

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 to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, caution is warranted in specific populations. The medication is not recommended for use in children under 12 years of age. Patients with a persistent or chronic cough, such as those resulting from smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
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 younger than 12 years.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to stop using the medication and consult a healthcare provider if their cough persists for more than 7 days, returns after resolution, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should also be encouraged to discuss their medical history with their healthcare provider prior to use, particularly if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be advised to consult a healthcare provider if their cough is accompanied by excessive phlegm (mucus) to ensure appropriate management and care.

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 controlled temperature range of 20° to 25°C (68° to 77°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.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. It is contraindicated for use in children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin, 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 Guaifenesin, 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.