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Guaifenesin 100mg/5ml

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This product has been discontinued

Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
November 20, 2024
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
November 20, 2024
Manufacturer
Belleview Biosciences
Registration number
M012
NDC root
84447-101

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Drug Overview

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear your airways more effectively. It's commonly used when you have conditions that cause excessive mucus production, helping to alleviate discomfort and improve your breathing.

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 the 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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 to 4 teaspoonfuls every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If you're giving this medication to children aged 6 to under 12 years, the dosage is 1 to 2 teaspoonfuls every 4 hours. For younger children, specifically those aged 2 to under 6 years, you can give them 1/2 to 1 teaspoonful every 4 hours.

If your child is under 2 years old, it's best to consult a doctor before administering this medication. Always keep track of how many doses you've given to avoid taking too much within a day.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow the guidance provided by your healthcare professional.

Side Effects

Before using this medication, it's important to consult with your doctor 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. You should also stop using the medication and seek medical advice if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious health issue.

If you are pregnant or breastfeeding, please talk to a healthcare professional before using this product. Additionally, keep this medication out of reach of children, and in the event of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it's important to consult your doctor 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 like fever, rash, or a persistent headache, stop using the medication and contact your doctor, as these could indicate a more serious issue.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product. Always keep this medication out of reach of children, and 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 symptoms that are more severe than what you would typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring 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

When giving medication to children, it's important to follow the recommended dosages based on their age. For children aged 6 years to under 12 years, you can administer 1 to 2 teaspoonfuls every 4 hours. For younger children, specifically those aged 2 to under 6 years, the dosage is reduced to ½ to 1 teaspoonful every 4 hours.

If your child is under 2 years old, it's crucial to consult a doctor before giving any medication. Always ensure you are following these guidelines to keep your child safe and healthy.

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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the bottle tightly closed when you’re not using it.

Once you open the bottle, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You should take this medication orally. Before using it, consult your doctor if you have a cough with excessive mucus, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. 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 may indicate a serious condition.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Always keep it out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

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

What are the dosage recommendations for adults?

Adults and children 12 years and over should take 2-4 teaspoonfuls every 4 hours.

What should I do if I have a cough with too much phlegm?

You should ask a doctor before use if you have a cough that occurs with too much phlegm (mucus).

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.

Is this drug safe to use during pregnancy or breastfeeding?

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

What is the maximum number of doses I can take in a day?

Do not take more than 6 doses in any 24-hour period.

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 this drug?

Store at 20°C to 25°C (68°F to 77°F) and protect from light. Keep the bottle tightly closed when not in use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 100mg/5ml (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 100mg/5ml.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 100mg/5ml, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

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 recommended dosage for the medication varies by age group and should not exceed 6 doses within a 24-hour period.

For adults and children aged 12 years and older, the dosage is 2 to 4 teaspoonfuls administered every 4 hours.

For children aged 6 years to under 12 years, the dosage is 1 to 2 teaspoonfuls every 4 hours.

For children aged 2 years to under 6 years, the dosage is 1/2 to 1 teaspoonful every 4 hours.

For children under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Healthcare professionals should ensure that patients adhere to the maximum dosage limit to avoid potential adverse effects.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they experience a cough that is associated with excessive phlegm (mucus) or if the cough is chronic, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

In the event that a 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 seek medical advice. These symptoms may indicate a serious underlying condition that requires further evaluation.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare provider before using this product to ensure safety for both the mother and child.

This product should be stored out of reach of children. In the case of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is advised to consult a doctor prior to use if the patient has a cough that occurs with excessive phlegm (mucus) or if the cough is chronic, such as that which may occur with smoking, asthma, chronic bronchitis, or emphysema.

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

For those who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this medication. Additionally, the product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 100mg/5ml (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 100mg/5ml.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may be administered 1-2 teaspoonfuls every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 1/2 to 1 teaspoonful every 4 hours. In children under 2 years of age, it is advised to consult a doctor before administration.

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. 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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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 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 considered as part of standard clinical practice.

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 symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is vital for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nausea, vomiting, and gastrointestinal disturbances. These events have been documented in the context of routine pharmacovigilance activities.

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 for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients to consult a doctor prior to use if they experience a cough accompanied by excessive phlegm, or if the cough is chronic, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients should discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, pregnant or breastfeeding patients should consult a healthcare professional before using the medication. It is important to keep the product out of reach of children, and in the event of an overdose, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Guaifenesin 100mg/5ml, 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 100mg/5ml, 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.