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Guaifenesin Strawberry-Banana Flavor

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Active ingredient
Guaifenesin 100 mg/5 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
June 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 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
June 18, 2025
Manufacturer
Innovida Pharmaeutique Corporation
Registration number
M012
NDC root
71800-059
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

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. If you're dealing with congestion or a cough, this drug can assist in alleviating those symptoms.

Uses

If you're dealing with a cough that produces mucus, this medication can help. It works by loosening phlegm (a type of thick mucus) and thinning out bronchial secretions. This makes it easier for you to cough up the mucus, leading to a more productive cough. By clearing out the mucus, you can breathe more easily and feel more comfortable.

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 should take 2 to 4 teaspoonfuls (5 mL) every 4 hours, but remember not to exceed 6 doses in a 24-hour period.

If the patient is under 12 years of age, it's crucial to consult a physician before administering the medication. This ensures that the child receives the appropriate care and dosage tailored to their specific needs. Always adhere to these guidelines for the best results.

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, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this product. You should not use it for a persistent or chronic cough, especially if it’s related to smoking, asthma, chronic bronchitis, or emphysema, unless your doctor advises you to do so. If your cough lasts more than a week, comes back frequently, or is accompanied by a fever, rash, or a persistent headache, you should stop using the product and consult a doctor, as these could be signs of a more serious condition.

If you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Always keep it out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should avoid using this product if you have a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, especially if it comes with excessive mucus, unless your doctor advises otherwise. If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, it's important to stop using the product and consult your doctor, as these could be signs of a more serious condition.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Always keep it out of reach of children. In the event of an overdose, seek medical help immediately or contact a 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.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your safety is the top priority.

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

If your child is under 12 years old, it's important to consult a physician before giving them this medication. For those aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls (5 mL) every 4 hours, but be sure not to exceed 6 doses in a 24-hour period. Always keep the medication 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 paramount, so following these guidelines is essential.

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 issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment 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, based on the available information, this medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). This temperature range helps maintain its effectiveness.

When handling the product, be sure to check the tamper-evident seal under the cap. If the seal is torn, broken, or missing, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Always keep this medication out of the reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What does this drug do?

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

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

Adults and children 12 years of age and over should take 2-4 teaspoonfuls (5 mL) every 4 hours, not exceeding 6 doses in a 24-hour period.

What should I do if I am under 12 years old?

If you are under 12 years of age, consult a physician before use.

Are there any warnings I should be aware of?

Do not use this product for persistent or chronic coughs unless directed by a doctor. If your cough persists for more than a week or is accompanied by a fever, rash, or persistent headache, consult a doctor.

What should I do if I am pregnant or breastfeeding?

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

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 right away.

How should I store this drug?

Store at room temperature between 15°-30°C (59°-86°F) and do not use if the seal under the cap is torn, broken, or missing.

Is there any information on drug interactions?

No specific drug interactions are mentioned in the provided information.

Is this drug safe for elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

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

Packaging configurations for Guaifenesin Strawberry-Banana Flavor.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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, thereby facilitating more productive coughs.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 to 4 teaspoonfuls (5 mL) every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period to avoid potential overdose.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing and administration guidance.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in individuals experiencing persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, it should not be used when cough is accompanied by excessive phlegm (mucus) unless specifically directed by a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical consultation if the cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

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

This product must be kept out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is contraindicated for individuals experiencing persistent or chronic cough, such as those related to smoking, asthma, chronic bronchitis, or emphysema, particularly when accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

Patients are advised to discontinue use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, it is recommended that pregnant or breastfeeding individuals seek advice from a health professional prior to using this product.

To ensure safety, this product should be kept out of the reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. 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 Strawberry-Banana Flavor (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin Strawberry-Banana Flavor.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2-4 teaspoonfuls (5 mL) every 4 hours, with a maximum of 6 doses in a 24-hour period. It is essential to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 efficacy, 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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

There is no specific information available 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 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 at 1-800-222-1222. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential. Management of an overdose typically involves supportive care and may require specific interventions based on the clinical presentation.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate treatment protocols as guided by the severity of the symptoms and the specific circumstances of the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the seal under the cap before use; the product should not be utilized if the seal is torn, broken, or missing.

For optimal storage, the product must be kept at room temperature, within the range of 15° to 30°C (59° to 86°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of the reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin Strawberry-Banana Flavor, 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 Strawberry-Banana Flavor, 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.