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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 2020
Label revision date
December 1, 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 2020
Label revision date
December 1, 2023
Manufacturer
Aurohealth LLC
Registration number
ANDA210453
NDC root
58602-853
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Guaifenesin is an expectorant medication available in extended-release tablets of 600 mg. It is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By relieving chest congestion, Guaifenesin can help make your coughs more productive, allowing you to breathe more comfortably.

This medication is formulated to provide relief over a 12-hour period, ensuring that you can manage your symptoms effectively 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 helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. If you're experiencing chest congestion, this medication can also provide relief by thinning and loosening the mucus in your airways.

Overall, it works to improve your respiratory comfort and support your body's natural ability to clear out mucus.

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 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, 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 is accompanied by 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 noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any 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, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious condition.

Before using this medication, it's important to 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 be aware of some key warnings and precautions when using this medication. First, do not use it 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 also stop taking the 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 of this medication, it's important to know that there is no specific information available about what to expect or how to respond. Since the drug insert does not provide details on overdose, you should be cautious and monitor for any unusual symptoms.

If you experience any concerning signs or symptoms, such as extreme drowsiness, confusion, or difficulty breathing, seek medical help immediately. It's always better to err on the side of caution, so if you have any doubts or concerns about a possible overdose, contact a healthcare professional or emergency services right away.

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 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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you are caring for an older adult, be attentive to any changes in their health or behavior after starting a new medication. Regular check-ins with a healthcare professional can help manage any potential risks and ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how it should be managed in the context of liver impairment.

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 help monitor your liver function and make any necessary adjustments to your medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

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?

Guaifenesin is an expectorant available in extended-release tablets of 600 mg that helps loosen phlegm (mucus) and thin bronchial secretions.

How does Guaifenesin work?

It helps loosen phlegm and thin bronchial secretions to make coughs more productive and relieve chest congestion.

What are the dosage instructions for Guaifenesin?

Adults and children 12 years and older should take 1 or 2 tablets every 12 hours, not exceeding 4 tablets in 24 hours. Do not use for children under 12 years of age.

Can I take Guaifenesin with food?

Yes, Guaifenesin can be taken without regard for the timing of meals.

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.

Are there any warnings for using Guaifenesin?

Do not use Guaifenesin for children under 12 years of age, and consult a doctor if you have a persistent or chronic cough.

What should I do in case of an overdose?

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

Is it safe to use Guaifenesin during pregnancy or breastfeeding?

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

How should Guaifenesin be stored?

Store Guaifenesin 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

Healthy Living™ Guaifenesin Extended-Release Tablets are formulated as an expectorant, designed to relieve chest congestion by thinning and loosening mucus. Each tablet contains 600 mg of guaifenesin and is intended for a 12-hour duration of action. The product is available in a package containing 20 extended-release tablets. The National Drug Code (NDC) for this formulation is 58602-853-73.

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 to 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

Use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this restriction is communicated clearly to caregivers and patients to prevent inappropriate use.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers should advise patients and caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and intervention. Regular monitoring of these symptoms is essential to ensure patient safety and appropriate management.

Side Effects

Patients should be aware that the use of this medication is not recommended for children under 12 years of age. In clinical practice, 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 may indicate a serious underlying condition.

Before initiating treatment, patients should seek medical advice if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

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 are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 maternal health. 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 health 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 context of overdosage, it is important to note that the available sections of the drug insert do not provide any specific information regarding potential overdosage scenarios.

Given the absence of documented overdosage data, healthcare professionals are advised to exercise caution and consider standard management protocols for suspected overdosage of any medication. In the event of an overdose, it is recommended that healthcare providers monitor the patient closely for any adverse effects and initiate supportive care as necessary.

Should symptoms arise, symptomatic treatment should be employed, and appropriate medical intervention should be sought. It is also advisable to contact a poison control center or seek emergency medical assistance for further guidance on managing potential overdosage cases.

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

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated phone number provided for this purpose.

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.

Healthcare providers should instruct patients to discontinue use and consult a doctor 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.

It is important for patients to consult with their healthcare provider prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema.

Additionally, patients should be encouraged to seek medical advice before using the medication if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled room temperature, specifically between 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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.