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Guaifenesin 200mg

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Active ingredient
Guaifenesin 200 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 2025
Label revision date
August 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 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 2025
Label revision date
August 22, 2025
Manufacturer
HEALTHLIFE OF USA LLC
Registration number
M012
NDC root
69517-148
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

You may be looking for a medication that provides temporary relief from symptoms associated with a congested chest and cough. This type of medication works by helping to alleviate discomfort and improve breathing, making it easier for you to manage these symptoms. If you're experiencing a cough or chest congestion, this medication could be a supportive option to consider for short-term relief.

Uses

If you're dealing with a congested chest and a persistent cough, this medication can provide temporary relief from these symptoms. It works by helping to ease the discomfort associated with chest congestion, making it easier for you to breathe and feel more comfortable. Remember, this is meant for short-term use to help manage your symptoms effectively.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet once a day. It’s important to remember not to exceed 4 doses within a 24-hour period, as taking more than this can be harmful.

For children under 12 years of age, this medication is not recommended, so please avoid using it for younger children. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

If you experience a persistent cough that lasts more than a week, recurs frequently, or is accompanied by symptoms like fever, rash, or a lasting headache, it's important to consult a doctor, as this could indicate a serious condition. Additionally, if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus, please speak with your healthcare provider before using this product.

While using this medication, be sure to follow the recommended dosage and avoid alcohol, benzodiazepines, or opioids, as these can interact negatively. If your cough continues for more than seven days, stop using the product and seek medical advice. In the event of an overdose, contact a medical professional or the Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

If you have a cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, it’s important to see a doctor, as this could indicate a serious condition. Before using this product, consult your doctor if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus.

While using this product, make sure to follow the recommended dosage and avoid alcohol, benzodiazepines (a type of sedative), or opioids (strong pain relievers). If your cough continues for more than 7 days, stop using the product and contact your doctor. In the event of an overdose, seek medical help immediately or call the Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. 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 prioritize your health and safety by reaching out for help if you think an overdose has occurred.

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 is not recommended for children under 12 years old. If your child is 12 years or older, they can take one tablet a day. Always ensure that medications are kept out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is a top priority, so please follow these guidelines carefully.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice. They can help determine the best approach to medication management, considering any unique health needs or conditions that may be present.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any particular changes you may need to make regarding your treatment.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can help you understand how your condition may affect your medication and what steps to take for your well-being.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when using this product. You should avoid consuming alcohol, benzodiazepines (a type of medication often used for anxiety), or opioids (strong pain relievers) while using it. Mixing these substances can lead to serious health risks.

Always discuss any medications or substances you are taking with your healthcare provider. They can help you understand potential interactions and ensure your safety while using this product.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F), but it can safely be kept in a range between 15°-30°C (59°-86°F). Make sure to keep it in a dry place and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it 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 the primary use of this drug?

This drug provides temporary symptomatic relief from congested chests and cough.

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

Adults and children 12 years of age and over should take 1 tablet a day.

Can children under 12 use this medication?

No, children under 12 years should not use this medication.

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

If your cough lasts for more than 7 days, you should stop use and consult a doctor.

Are there any warnings associated with this drug?

Yes, a persistent cough may indicate a serious condition. Consult a doctor if your cough persists for more than 1 week or is accompanied by fever, rash, or persistent headache.

What should I avoid while using this product?

Do not exceed the recommended dosage and avoid consuming alcohol, benzodiazepines, or opioids.

What should I do in case of an overdose?

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

Is it safe to use this drug during pregnancy or breastfeeding?

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

How should I store this medication?

Store at 25°C (77°F) with excursions between 15°-30°C (59°-86°F) in a dry place, and do not expose it to heat.

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)

Uses and Indications

This drug is indicated for the temporary symptomatic relief of congested chests and cough. It is intended for use in patients experiencing these symptoms, providing a short-term solution to alleviate discomfort associated with respiratory congestion.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet once daily. For children under 12 years of age, the use of this medication is not recommended.

It is imperative that patients do not exceed 4 doses within a 24-hour period to avoid potential adverse effects.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

A persistent cough may indicate a serious underlying condition. Healthcare professionals should advise patients to seek medical consultation if a cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Prior to recommending this product, it is essential to inquire whether the patient has a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, caution should be exercised if the cough is accompanied by excessive phlegm (mucus).

When utilizing this product, it is critical to adhere to the recommended dosage guidelines. Patients should be advised against the consumption of alcohol, benzodiazepines, or opioids during treatment, as these substances may exacerbate potential side effects.

If the cough persists beyond seven days, patients should be instructed to discontinue use and consult a healthcare professional. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. A persistent cough may indicate a serious underlying condition; therefore, if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to consult a healthcare professional.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, a cough accompanied by excessive phlegm (mucus) warrants consultation with a doctor.

While using this product, it is crucial for patients to adhere to the recommended dosage and to avoid the consumption of alcohol, benzodiazepines, or opioids, as these substances may exacerbate adverse effects.

Patients should discontinue use and seek medical advice if their cough lasts longer than seven days. In the event of an overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

Consumption of alcohol, benzodiazepines, or opioids is contraindicated during the use of this product due to the potential for significant pharmacodynamic interactions. The combination of these substances may enhance central nervous system (CNS) depression, leading to increased risks of sedation, respiratory depression, and other adverse effects.

It is advised that patients avoid these substances entirely while undergoing treatment with this product to mitigate the risk of serious complications. Monitoring for signs of excessive sedation or respiratory distress is recommended if accidental exposure occurs.

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

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet per day.

Healthcare professionals should advise caregivers to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance and support.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is essential to follow established protocols for overdose management to ensure the best possible outcomes for affected individuals.

Nonclinical Toxicology

There are no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects have been reported. The available data does not provide any insights into animal pharmacology and toxicology.

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 for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to keep the product in a dry place and to avoid exposure to heat to maintain its integrity.

Additionally, the product features a tamper-evident safety seal. It is crucial to inspect the seal before use; the product should not be used if the imprint safety seal under the cap is broken or missing.

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.