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Guaifed

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Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
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
October 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
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
October 14, 2025
Manufacturer
Aldama Pharmaceuticals, Inc
Registration number
M012
NDC root
73564-801
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Guifed is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. By doing this, it can assist your body in clearing mucus from your airways, which may help you breathe easier when you're dealing with respiratory issues.

This medication is particularly useful when you have a cough that is accompanied by congestion, as it works to improve the effectiveness of your cough reflex. If you're experiencing such symptoms, Guifed may be a helpful option to consider.

Uses

This medication is designed to help you if you're dealing with a cough that produces phlegm (a thick mucus). It works by loosening the phlegm and thinning out bronchial secretions, making it easier for you to cough up the mucus. This can help make your cough more productive, allowing you to clear your airways more effectively.

You can feel confident using this medication, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with it.

Dosage and Administration

When you need relief, you can take this medication every 4 hours as needed, but make sure not to exceed 6 doses in a 24-hour period. It's important to follow the recommended dosage to avoid any potential issues.

For adults and children aged 12 years and older, the typical dose is between 10 mL to 20 mL, which is equivalent to 2 to 4 teaspoonfuls. If you are considering this medication for a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to stick to the recommended amounts for your safety.

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 safety by following the recommended instructions and seeking medical advice when necessary.

Side Effects

You should avoid using this product if you have ever had an allergic reaction to any of its ingredients. It's important to consult with a doctor before using it if you have a cough that produces a lot of mucus or if your cough is chronic, which can happen with conditions like smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, you should stop using the product and seek medical advice, as these could indicate a more serious health issue.

Warnings and Precautions

You should not use this product if you have ever had an allergic reaction to any of its ingredients. Before using it, consult your doctor if you have a cough that produces a lot of phlegm (mucus) or if your cough is chronic, such as from smoking, asthma, chronic bronchitis, or emphysema.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop using the product and call your 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 health issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it's important to be aware of potential signs of overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical help. Contact your local emergency services or go to the nearest hospital. If possible, have the medication packaging with you to provide healthcare professionals with important information. Always remember that it's better to be safe and get checked out if you have any concerns about an overdose.

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

When considering this medication for your child, it's important to note that the dosage differs based on age. For adults and children aged 12 years and older, the recommended dose is between 10 mL to 20 mL, which is equivalent to 2 to 4 teaspoonfuls. However, if your child is under 12 years old, you should consult a doctor before giving them this medication. This ensures that you receive the appropriate guidance tailored to your child's specific needs. Always prioritize safety and seek professional advice when it comes to medications for younger children.

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 before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 full list of medications and any health concerns during your appointments to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 15° and 30°C (59° and 86°F). It's important to keep it away from freezing temperatures and to protect it from light, as exposure can affect its quality.

When handling the product, check the foil seal over the bottle opening before use. If the seal is torn, broken, or missing, do not use the product, as this could compromise its safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Guifed used for?

Guifed helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

How should I take Guifed?

Take Guifed every 4 hours as needed, or as directed by your doctor. Do not take more than 6 doses in 24 hours.

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

Adults and children 12 years and over should take 10 mL to 20 mL (2 to 4 teaspoonfuls).

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 is accompanied by fever, rash, or persistent headache.

Are there any contraindications for using Guifed?

Do not use Guifed if you have ever had an allergic reaction to any of its ingredients.

Can I use Guifed if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

How should I store Guifed?

Store Guifed at room temperature between 15° - 30°C (59° - 86°F), protect it from freezing and light, and do not use if the foil seal is torn, broken, or missing.

Packaging Info

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

Packaging configurations for Guaifed.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. It helps to loosen phlegm and thin bronchial secretions, thereby making coughs more productive.

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

Dosage and Administration

The medication should be administered every 4 hours as needed, or as directed by a healthcare professional. It is imperative that patients do not exceed 6 doses within a 24-hour period and adhere strictly to the recommended dosage.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (equivalent to 2 to 4 teaspoonfuls) per administration. For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, or if the cough recurs or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

The use of this product is contraindicated in individuals with a known allergy to any of its ingredients. Healthcare professionals should ensure that patients are screened for such allergies prior to administration.

Patients should be advised to consult a physician before using this product if they present with a cough that is productive of excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These conditions may require alternative therapeutic approaches.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay to mitigate potential adverse effects.

Patients must be instructed to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that necessitates further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur in individuals with a history of allergic reactions to any of the ingredients in this formulation; therefore, it is contraindicated for such patients.

In clinical practice, it is advised that patients consult a healthcare professional prior to use if they experience a cough that is productive with excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are also instructed to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Guaifed.
Details

Pediatric Use

Pediatric patients aged 12 years and older may receive a dosage of 10 mL to 20 mL (2 to 4 teaspoonfuls). For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

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, as well as any available data regarding fetal outcomes and lactation. 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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain alert to the signs of overdose, and implement appropriate management strategies as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center.

Additionally, patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F).

To ensure the integrity of the product, it must be protected from freezing and light exposure. Additionally, healthcare professionals should verify that the foil seal over the bottle opening is intact; the product should not be used if the seal is torn, broken, or missing. Proper adherence to these storage and handling guidelines is crucial for maintaining product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifed, 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 Guaifed, 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.