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Guaifenesin 200mg

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This product has been discontinued

Active ingredient
Guaifenesin 200 mg
Other brand names
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 2019
Label revision date
October 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 mg
Other brand names
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 2019
Label revision date
October 7, 2024
Manufacturer
Marlex Pharmaceuticals Inc
Registration number
M012
NDC root
10135-681
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 is a medication that helps loosen phlegm (mucus) and thin bronchial secretions. By doing so, it aids in clearing the bronchial passageway of bothersome mucus, making coughs more productive. This can be particularly helpful when you're dealing with respiratory conditions that cause congestion and discomfort.

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. 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 concerned about such risks.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 years and older, you can take 1 to 2 tablets every 4 hours as needed. However, make sure not to exceed 6 doses within a 24-hour period.

Please note that this product is not suitable for children under 12 years of age, so if you're considering it for a younger child, it's best to consult a healthcare professional for appropriate alternatives. Always adhere to these guidelines to use the medication safely.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should take care to ensure the product is safe to use.

Do not use the product if the safety seal under the cap is broken or missing, as this indicates that the product may have been tampered with. Always check the seal before using to ensure your safety.

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 a doctor, as these could be signs of a more serious illness. Additionally, if you have a chronic cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema, you should speak with your doctor before using this medication.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Always be mindful of your symptoms and prioritize your health.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough produces a lot of phlegm (mucus), you should also seek medical advice.

You should stop using this medication and contact your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious condition. Always check that the safety seal under the cap is intact before use; do not use the product if it is broken or missing.

Keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

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; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious when it comes to 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

This product is not suitable for children under 12 years of age. If you have a child who is 12 years or older, you can give them 1 to 2 tablets every 4 hours as needed. However, it’s important to avoid using this medication for children younger than 12, as it is not intended for their use. Always consult with a healthcare professional if you have any questions or concerns about medication for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 your liver health might influence the treatment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver health and medication. They can help ensure that your treatment is safe and effective based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C and 30°C (59°F and 86°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

No further information is available.

FAQ

What is Guaifenesin used for?

Guaifenesin helps 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 and over should take 1 to 2 tablets every 4 hours, not exceeding 6 doses in 24 hours.

Is Guaifenesin safe for children under 12?

No, this product is not intended for use in children under 12 years of age.

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

You should stop using Guaifenesin and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Are there any warnings before using Guaifenesin?

Yes, ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by too much phlegm (mucus).

What should I do in case of an overdose?

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

Can I use Guaifenesin if I am pregnant or breastfeeding?

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

How should Guaifenesin be stored?

Store Guaifenesin at a temperature between 15°C-30°C (59°F-86°F).

What should I do if the safety seal under the cap is broken or missing?

Do not use Guaifenesin if the safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 200mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 200mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 200mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Guaifenesin is provided in a dosage form of 200 mg per tablet. Each bottle contains 100 tablets. The product is identified by the National Drug Code (NDC) 10135-0681-01.

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 passageway.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 1 to 2 tablets every 4 hours, as needed. It is important to note that no more than 6 doses should be taken within a 24-hour period. This product is contraindicated for use in children under 12 years of age. Healthcare professionals should ensure that patients adhere to these guidelines to avoid potential overdose and ensure safe usage.

Contraindications

Use is contraindicated if the tamper-evident safety seal under the cap is broken or missing. This precaution is necessary to ensure the integrity and safety of the product.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before using this product.

If the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, it is imperative to discontinue use and consult a healthcare provider. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

This product features a tamper-evident safety seal. It should not be used if the seal under the cap is broken or missing, as this may compromise the integrity of the product.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 that patients 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, patients 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 lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying illness.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center.

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 based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 200mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 200mg.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. There are no established safety or efficacy profiles for children under 12 years, and therefore, use in this population is contraindicated.

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 adverse effects or changes in therapeutic response, 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 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 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 specific symptoms of an overdose may vary depending on the 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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 in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of the medication; they should stop 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.

Additionally, healthcare providers should emphasize the importance of product integrity by instructing patients to check the tamper-evident seal. Patients should not use the product if the safety seal under the cap is broken or missing, as this could compromise the safety and efficacy of the medication.

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 temperature range of 15°C to 30°C (59°F to 86°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

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifenesin 200mg, 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 200mg, 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.