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Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended...

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Active ingredient
Guaifenesin 600–1200 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 2020
Label revision date
April 8, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600–1200 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 2020
Label revision date
April 8, 2023
Manufacturer
Innovus Pharmaceuticals, Inc.
Registration number
ANDA213420
NDC roots
57483-270, 57483-280
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

C'rcle Guaifenesin Extended-Release Tablets are a type of medication known as an expectorant, available in two strengths: 600 mg and 1200 mg. These tablets are designed to help you by loosening phlegm (mucus) and thinning bronchial secretions, which can make it easier to clear mucus from your airways and make your coughs more productive.

By using this medication, you can find relief from the discomfort of congestion and improve your ability to breathe more easily. It comes in extended-release bi-layer tablets, allowing for a gradual release of the active ingredient to provide longer-lasting effects.

Uses

If you're dealing with a cough that comes with thick mucus, this medication can help. It works by loosening phlegm (a type of mucus) and thinning out bronchial secretions. This makes it easier for you to clear out the mucus from your airways, leading to more productive coughs. By doing so, it can help you breathe more comfortably and reduce the discomfort associated with congestion.

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, and you can take it at any time, regardless of meals.

For adults and children aged 12 and older, if you are using the 600 mg tablets, you can take 1 or 2 tablets every 12 hours, but be careful not to exceed 4 tablets in a 24-hour period. If you are using the 1200 mg tablets, take 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. Please note that 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 considering 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 noted risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

It's important to be aware of certain warnings and precautions when using this medication. You should not use it if you are under 12 years old. If you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus, consult your doctor before using this product.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious condition. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Before using it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the medication and contact your doctor, as these may indicate a more serious condition. In the event of an overdose, seek emergency medical help or call a Poison Control Center immediately 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.

Do not 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 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 are no specific guidelines or recommendations for older adults regarding this medication, it's always important to approach any new treatment with caution. Since the insert does not mention any dosage adjustments or safety concerns for elderly patients, you should still consult with your healthcare provider to ensure that this medication is appropriate for your individual health needs.

If you or a loved one is an older adult, discussing any potential risks or benefits with a doctor can help ensure safe and effective use of the medication. Always prioritize open communication with your healthcare team to address any questions or concerns you may have.

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 should be used 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 you understand how to manage your treatment effectively while considering your kidney health.

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 safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

When handling the product, be sure to check the packaging carefully. Do not use it if the carton is open or if the printed seal on the blister pack is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is C'rcle Guaifenesin Extended-Release Tablets used for?

C'rcle Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

How should I take C'rcle Guaifenesin Extended-Release Tablets?

You should take the tablets with a full glass of water and not crush, chew, or break them. Adults and children 12 years and older can take 1 or 2 tablets every 12 hours, but do not exceed the recommended daily limit.

What is the dosage for adults and children over 12?

For the 600 mg tablets, take 1 or 2 tablets every 12 hours, not exceeding 4 tablets in 24 hours. For the 1200 mg tablets, take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours.

Can children under 12 use this medication?

No, C'rcle 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?

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

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using C'rcle Guaifenesin.

What should I do in case of an overdose?

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

Are there any contraindications for using this medication?

There are no specific contraindications mentioned, but you should not use it if you have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema without consulting a doctor.

How should I store C'rcle Guaifenesin Extended-Release Tablets?

Store the tablets between 20-25°C (68-77°F) and do not use if the carton is open or if the printed seal on the blister is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg (guaifenesin extended-release). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg.
Details

Drug Information (PDF)

This file contains official product information for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

C'rcle Guaifenesin Extended-Release Tablets are available in two formulations: 600 mg and 1200 mg, both serving as expectorants. The 600 mg formulation is supplied in a package containing 100 extended-release bi-layer tablets, organized in a configuration of 20 blisters with 5 tablets each. The 1200 mg formulation is provided in a package of 56 extended-release bi-layer tablets, arranged in 14 blisters with 4 tablets each.

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 mucus clearance, this medication aims to make 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

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 ingestion. This medication can be administered without regard to the timing of meals.

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

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

  • For the 1200 mg formulation: Administer 1 tablet every 12 hours, with a maximum of 2 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 in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

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

Warnings indicate that the medication is not recommended for use in children under 12 years of age. Patients are advised to 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, individuals 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 persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional before using this medication.

It is crucial to keep this medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance 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 Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg (guaifenesin extended-release). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 mg.
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. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as with any medication prescribed to elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate risk assessment and management.

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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition, including vital signs and level of consciousness, and initiate appropriate interventions based on the clinical presentation.

In summary, prompt action and appropriate medical response are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 doctor 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 underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough 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 a tamper-evident package. It is essential to inspect the carton before use; do not use if the carton is open or if the printed seal on the blister is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 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 Crcle Guaifenesin Extended-Release Tablets, 600 mg, Crcle Guaifensin Extended Release Tablet, 1200 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.

Learn more in our Editorial Policy

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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.