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Guaifenesin 1200 mg, Guaifenesin 600 mg

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Active ingredient
Guaifenesin 600–1200 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 2022
Label revision date
November 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600–1200 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 2022
Label revision date
November 9, 2024
Manufacturer
Strategic Sourcing Services, LLC
Registration number
ANDA215932
NDC roots
70677-1257, 70677-1258
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 contain 600 mg of guaifenesin, a medication designed to help loosen phlegm (mucus) and thin bronchial secretions. By doing so, it aids in clearing the bronchial passageways of bothersome mucus, making your coughs more productive. This can be particularly helpful when you're dealing with respiratory conditions that involve congestion.

Uses

If you're dealing with a cough that produces mucus, this medication can help. It works by loosening phlegm (a type of mucus) and thinning out bronchial secretions. This makes it easier for your body to clear out the mucus from your airways, leading to more productive coughs. By clearing the bronchial passageways, you can find relief from the discomfort caused by excess mucus.

Dosage and Administration

When taking this medication, it's important to swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can affect how the medicine works. Make sure to take it with a full glass of water, and you can take it at any time, regardless of meals.

For adults and children aged 12 and older, you can take either 1 or 2 extended-release tablets every 12 hours, but be careful not to exceed 4 tablets in a 24-hour period if you're using the 600 mg strength. If you're using the 1200 mg strength, stick to 1 tablet every 12 hours, and do not take more than 2 tablets in a day. This medication is not recommended for children under 12 years of age.

What to Avoid

It's important to be aware of specific guidelines when using this medication. You should not use it for children under 12 years of age, as it may not be safe for them.

Currently, there are no specified contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Side Effects

If you experience a cough that 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 your doctor, as these could indicate a serious illness. Additionally, if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus, you should speak with your doctor before using this medication.

This product is not recommended for children under 12 years of age. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not use this medication if you are under 12 years of age. Before using it, 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 occurs with a fever, rash, or persistent headache, stop taking the medication and contact your doctor, as these may be signs of a more serious condition. In the event of an overdose, seek emergency medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. 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 keep emergency contact information handy and be aware of the signs of overdose to ensure 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

It’s important to know that this medication should not be given to children under 12 years of age. For those who are 12 years and older, the recommended dosage is either 1 or 2 extended-release tablets every 12 hours, but you should not exceed 4 tablets in a 24-hour period if you are using the 600 mg strength. If you are using the 1200 mg strength, the dosage is 1 extended-release tablet every 12 hours, with a maximum of 2 tablets in 24 hours.

Always follow these guidelines carefully to ensure safety and effectiveness for your child or teenager. If you have any questions or concerns about the medication, consult your healthcare provider for more information.

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 to using this medication safely and effectively, considering any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

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.

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

Adults and children 12 years of age and over can take 1 or 2 extended-release tablets every 12 hours, not exceeding 4 tablets in 24 hours for the 600 mg dosage.

Can children under 12 use Guaifenesin Extended-Release Tablets?

No, Guaifenesin Extended-Release Tablets 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 using the medication and ask your doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

What should I do in case of an overdose?

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

How should I take Guaifenesin Extended-Release Tablets?

Take the tablets with a full glass of water and do not crush, chew, or break them.

Is there any specific information for pregnant or breastfeeding women?

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

What are the storage conditions for this medication?

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

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 1200 mg, Guaifenesin 600 mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 1200 mg, Guaifenesin 600 mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 1200 mg, Guaifenesin 600 mg, 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 used to relieve chest congestion. The tablets are formulated for extended-release, allowing for prolonged therapeutic effects.

Uses and Indications

This drug is indicated for the management of respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucociliary function, this medication makes coughs more productive, thereby alleviating symptoms associated with respiratory congestion.

Limitations of Use: This drug is not intended for the treatment of conditions that do not involve mucus production or for patients who do not require assistance in clearing bronchial secretions.

Dosage and Administration

Extended-release tablets should not be crushed, chewed, or broken prior to administration. Each tablet must be taken with a full glass of water. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is as follows:

  • For the 600 mg formulation: Administer 1 or 2 extended-release tablets every 12 hours, with a maximum of 4 extended-release tablets in a 24-hour period.

  • For the 1200 mg formulation: Administer 1 extended-release tablet every 12 hours, with a maximum of 2 extended-release tablets in a 24-hour period.

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

Contraindications

Use is contraindicated in children under 12 years of age.

Warnings and Precautions

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

Healthcare professionals should advise patients to consult a physician 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 seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Patients are instructed to discontinue use and contact their healthcare provider if the 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.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, returns after resolution, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying illness.

Before using this medication, patients should seek medical advice if they have a persistent or chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

This medication is not recommended for use in children under 12 years of age. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 1200 mg, Guaifenesin 600 mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 1200 mg, Guaifenesin 600 mg.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents and children aged 12 years and older, the recommended dosage is 1 or 2 extended-release tablets every 12 hours, with a maximum of 4 extended-release tablets in a 24-hour period for the 600 mg formulation. For the 1200 mg formulation, the dosage is 1 extended-release tablet every 12 hours, not to exceed 2 extended-release tablets in 24 hours. Caution is advised when prescribing to this age group, ensuring adherence to the specified dosage 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

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

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

Patient Counseling

Healthcare providers should advise patients 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 to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice 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 for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°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 to prevent degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin 1200 mg, Guaifenesin 600 mg, 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 1200 mg, Guaifenesin 600 mg, 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.

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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.