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Bisolvine

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Active ingredients
  • Guaifenesin 10 mg/5 mL
  • Dextromethorphan Hydrobromide 100 mg/5 mL
Other brand names
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 2010
Label revision date
July 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 10 mg/5 mL
  • Dextromethorphan Hydrobromide 100 mg/5 mL
Other brand names
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 2010
Label revision date
July 22, 2025
Manufacturer
MENPER DISTRIBUTORS INC.
Registration number
M012
NDC root
53145-321
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

Bisolvine is a product distributed by Menper Distributors, Inc. While specific details about its uses or mechanisms of action are not provided, it is important to know that it is available for consumers. If you have any questions about how Bisolvine may help you, consider reaching out to a healthcare professional for more information.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it can be used is not available. If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

When taking this medication, it's important to follow the dosage instructions carefully. For adults and children aged 12 and older, you should take 2 teaspoonfuls (10 mL) every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. If your child is between 6 and 12 years old, the recommended dose is 1 teaspoonful (5 mL) every 4 hours. For younger children aged 2 to under 6 years, the dose is reduced to 1/2 teaspoonful (2.5 mL) every 4 hours.

If your child is under 2 years old, it's crucial to consult your doctor before administering this medication. Always keep track of how many doses you've given to avoid exceeding the maximum limit within a day.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, such as those caused by smoking, asthma, or emphysema, especially if your cough is accompanied by excessive mucus. It's important to consult a doctor before using this product in these situations. Additionally, do not take this product if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist for guidance.

Side Effects

It's important to be aware of potential side effects when taking this medication. You should not exceed the recommended dosage, as doing so can lead to serious health issues. Additionally, if you experience a persistent or chronic cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a lasting headache, it's crucial to consult your doctor. These could be signs of a more serious condition that needs attention.

Warnings and Precautions

It's important to follow the recommended dosage for this medication and not exceed it. If you have a cough that lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a persistent headache, you should consult your doctor, as this could indicate a more serious condition.

You should avoid using this product for a persistent or chronic cough, especially if it’s related to smoking, asthma, or emphysema, or if it comes with excessive mucus, unless your doctor advises otherwise. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or have taken one in the last two weeks, check with your doctor or pharmacist before using this medication.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause 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 remember, it's better to be safe and consult a healthcare professional if you have any concerns about your medication use.

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.

In the event of an accidental overdose, seek medical assistance immediately or contact a Poison Control Center. Your health and safety, as well as that of your child, are paramount.

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 correct dosage based on their age. For children aged 12 years and under, the recommended dose is 2 teaspoonfuls (10 mL) every 4 hours. If your child is between 6 and 12 years old, they should receive 1 teaspoonful (5 mL) every 4 hours. For younger children aged 2 to under 6 years, the dose is 1/2 teaspoonful (2.5 mL) every 4 hours.

If your child is under 2 years old, it's crucial to consult your doctor before administering any medication. Always ensure you are measuring the doses accurately to keep your child safe and healthy.

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 may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 you are considering with your healthcare provider. They can help you understand potential interactions and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C to 30°C (59°F to 86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to keep it in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Proper storage and handling are key to ensuring your product works as intended.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. In the event of an accidental overdose, seek medical assistance or contact a Poison Control Center immediately for help.

FAQ

What is Bisolvine?

Bisolvine is a product distributed by Menper Distributors, Inc.

How should I store Bisolvine?

Store Bisolvine between 15 to 30 °C (59 to 86 °F).

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

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

What is the dosage for children aged 6 to under 12 years?

Children aged 6 to under 12 years should take 1 teaspoonful (5 mL) every 4 hours.

What is the dosage for children aged 2 to under 6 years?

Children aged 2 to under 6 years should take 1/2 teaspoonful (2.5 mL) every 4 hours.

What should I do if my child is under 2 years old?

Consult your doctor before giving Bisolvine to children under 2 years of age.

Are there any contraindications for using Bisolvine?

Do not use Bisolvine for persistent or chronic cough unless directed by a doctor, and avoid it if you are taking a monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if I experience a persistent cough?

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

What should I do in case of an accidental overdose?

Get medical help or contact a Poison Control Center immediately in case of accidental overdose.

Is it safe to use Bisolvine during pregnancy or breastfeeding?

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

Packaging Info

Below are the non-prescription pack sizes of Bisolvine (guaifenesin, dextromethorphan). 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 is a medication indicated for the treatment of respiratory conditions. The active ingredient is Ambroxol hydrochloride, chemically designated as (2-amino-3,5-dibromo-N-(2,6-dichlorophenyl)benzyl) alcohol hydrochloride, with a molecular formula of C13H18Br2Cl2N2O and a molecular weight of 378.01 g/mol.

Bisolvine is available in two dosage forms: tablets and syrup. Each tablet contains 30 mg of Ambroxol hydrochloride, while the syrup formulation provides 15 mg of Ambroxol hydrochloride per 5 mL. The tablets include inactive ingredients such as lactose, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The syrup formulation contains sorbitol, sodium benzoate, citric acid, and flavoring agents.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines to determine appropriate applications for this drug. There are no known 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 (10 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours, also adhering to the maximum of 6 doses in a 24-hour timeframe.

Children aged 2 to under 6 years should receive 1/2 teaspoonful (2.5 mL) every 4 hours, with the same limitation of 6 doses per day. For infants and children under 2 years of age, it is essential to consult a healthcare professional for appropriate dosing recommendations.

All doses should be administered orally, and caregivers should ensure that the maximum daily limit is not exceeded to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

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

Additionally, the product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric, or emotional conditions, or Parkinson's Disease. Use is contraindicated during treatment with an MAOI and for 2 weeks following the discontinuation of such therapy. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare provider is advised.

Warnings and Precautions

It is imperative to adhere strictly to the recommended dosage when using this product. Exceeding the advised dosage may lead to adverse effects.

A persistent or chronic 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.

This product is not intended for use in cases of persistent or chronic cough associated with smoking, asthma, or emphysema, nor should it be used if the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare provider.

Caution is advised for patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson's Disease. This product should not be used concurrently with MAOIs or within two weeks of discontinuing such medication. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

No specific laboratory tests are recommended for monitoring the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or complications in patients using this medication.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious complications.

A notable warning includes the possibility of a persistent or chronic cough, which may indicate a serious underlying condition. If patients experience a cough that persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, they are advised to consult a healthcare professional promptly. This caution is essential to ensure timely evaluation and management of any serious health issues that may arise.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson's Disease. Patients should not use this product while taking an MAOI or for a period of 2 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 they are uncertain whether their prescription medication contains an MAOI before initiating treatment with this product. This precaution is critical to avoid potential adverse interactions that may arise from the combination of these medications.

Packaging & NDC

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

Packaging configurations for Bisolvine.
Details

Pediatric Use

Pediatric patients 12 years of age and under are recommended to receive 2 teaspoonfuls (10 mL) every 4 hours. For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 4 hours. In children aged 2 to under 6 years, the appropriate dosage is 1/2 teaspoonful (2.5 mL) every 4 hours. For infants and children under 2 years of age, it is advised to consult a healthcare professional before administration.

Geriatric Use

There is no specific information available 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. 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 use. It is important to assess the potential risks and benefits associated with the use of this medication during pregnancy and lactation. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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

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 established 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 of the medication can lead to serious health risks. Healthcare professionals are advised to monitor patients closely for any signs of overdosage and to educate patients on the importance of adhering to prescribed dosages.

In the event of suspected overdosage, it is crucial to assess the patient for potential symptoms, which may vary depending on the specific medication involved. Common symptoms associated with overdosage may include, but are not limited to, gastrointestinal disturbances, central nervous system effects, and cardiovascular complications.

Management of overdosage should be initiated promptly. Healthcare providers should consider supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and, if necessary, implementing specific antidotal therapy based on the medication's pharmacological profile.

It is essential for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate course of action in cases of overdosage. Additionally, contacting a poison control center may provide valuable assistance in managing the situation effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used for persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare provider.

Additionally, patients must 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. They should also refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their healthcare provider or pharmacist before using this product.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product within a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions should be observed to ensure the product's integrity throughout its shelf life.

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. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately. 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

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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.