Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Bisolvine

Last content change checked dailysee data sync status

Active ingredients
  • Guaifenesin 100 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2019
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2019
Label revision date
July 22, 2025
Manufacturer
MENPER DISTRIBUTORS INC.
Registration number
M012
NDC root
53145-402
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 temporarily relieve cough caused by minor irritation in your throat and bronchial tubes, which can happen with the common cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. This means that when you do cough, it can help clear out mucus more effectively, providing you with some relief from your symptoms.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from a common cold, this medication can provide temporary relief. It works by helping to loosen phlegm (mucus) and thin out bronchial secretions, making your coughs more productive. This means that it can help you clear out mucus more effectively, which can be especially helpful when you're feeling under the weather.

Dosage and Administration

When taking 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 teaspoonfuls (which is 30 milliliters) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period.

If your child is under 12 years old, it's best to consult your doctor for the appropriate dosage. This will help ensure that your child receives the right amount for their age and weight. Always remember to follow these guidelines closely for the best results.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, especially if your cough is accompanied by excessive mucus. It's important to only use this product for these conditions if your doctor specifically directs you to do so.

Additionally, do not take this product if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's Disease. You should also wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist for guidance.

Side Effects

It's important to be aware of potential side effects when taking this medication. A persistent cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache could indicate a serious condition. If you experience any of these symptoms, please consult your doctor promptly for further evaluation.

Warnings and Precautions

It's important to follow the recommended dosage when using this product. If you develop a persistent cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, you should consult your doctor. This could indicate a more serious condition.

Avoid using this product for chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema, especially if you have a lot of mucus. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or if you have stopped taking one in the last two weeks, do not use this product without first checking with your doctor or pharmacist.

In case of an accidental overdose, seek medical help immediately or contact a Poison Control Center. Your health and safety are paramount, so please take these precautions seriously.

Overdose

Taking more medication than recommended can lead to an overdose, which is a serious situation. It’s important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding the recommended dosage can result in harmful effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and well-being by adhering to the prescribed dosage.

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 your doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 2 teaspoonfuls (30 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.

If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this medication to ensure it's safe for you and 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 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 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 be cautious when taking this product, especially if you are currently using or have recently stopped a prescription monoamine oxidase inhibitor (MAOI). MAOIs are medications often prescribed for depression, certain psychiatric conditions, or Parkinson's Disease. You should avoid using this product while on an MAOI and for at least two weeks after stopping it. If you're unsure whether your medication includes an MAOI, please consult your doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure they are safe and appropriate for you. This helps prevent potentially harmful interactions and ensures your overall health and well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect the product from light, so keep it in its original container and make sure that the container is tightly closed when not in use. Once you open the container, please remember to discard any remaining product after use to maintain safety and effectiveness.

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 this medication to ensure it's safe for you and your baby.

FAQ

What is the primary use of this drug?

This drug temporarily relieves cough due to minor throat and bronchial irritation, such as that caused by the common cold.

How does this drug help with coughs?

It 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 of age and older should take 2 teaspoonfuls (30 ml) every 4 hours, not exceeding 6 doses in 24 hours.

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

If you are under 12 years of age, consult your doctor before use.

Are there any contraindications for this drug?

Do not use this product for persistent or chronic coughs, or if you are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if my cough persists?

If your cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

What precautions should I take if I am pregnant or breastfeeding?

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

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Bisolvine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Bisolvine AloeMiel is a pharmaceutical product identified by its specific formulation. The effective date of the insert is February 18, 2022. The package label features a principal display panel that includes an image reference labeled as Bisolvine AloeMiel.jpg.jpg.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 teaspoonfuls (30 ml) every 4 hours, not to exceed 6 doses within a 24-hour period. For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with persistent or chronic cough, including those associated with smoking, asthma, chronic bronchitis, or emphysema, or when cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional. This is due to the potential for exacerbating underlying respiratory conditions.

Additionally, the product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's Disease. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare provider is advised.

Warnings and Precautions

It is imperative to adhere to the recommended dosage to avoid potential adverse effects. Exceeding the prescribed amount may lead to serious complications.

A persistent cough may indicate an underlying serious 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.

In the event of an accidental overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

This product is not intended for use in cases of persistent or chronic cough, including those associated with smoking, asthma, chronic bronchitis, or emphysema, particularly when accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare provider.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's Disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult with a healthcare professional or pharmacist prior to use.

Side Effects

Patients should be aware that a persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is essential to consult a healthcare professional for further evaluation. This warning highlights the importance of monitoring respiratory symptoms and seeking timely medical advice to address potential complications.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are a class of medications commonly prescribed for depression, psychiatric disorders, or Parkinson's Disease. Patients should not use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Bisolvine.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls (30 ml) every 4 hours, with a maximum of 6 doses in a 24-hour period.

It is important to keep this medication out of reach of children. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

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 potential 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 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 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 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

Exceeding the recommended dosage may lead to serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage, which can manifest through various symptoms depending on the specific medication involved.

In the event of suspected overdosage, immediate medical attention is essential. Healthcare providers should initiate appropriate management procedures, which may include supportive care and symptomatic treatment. It is crucial to assess the patient's condition thoroughly and implement interventions based on the severity of symptoms observed.

To prevent overdosage, it is imperative that healthcare professionals educate patients on the importance of adhering to prescribed dosages and the potential risks associated with exceeding these recommendations. Regular follow-up and patient counseling can significantly mitigate the risk of overdosage and ensure safe medication use.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 accidental overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should emphasize the necessity of keeping the medication out of reach of children. This precaution is vital to prevent accidental ingestion and ensure the safety of young individuals.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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