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Bisolvine

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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 2010
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 2010
Label revision date
July 22, 2025
Manufacturer
MENPER DISTRIBUTORS INC.
Registration number
M012
NDC root
53145-322
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 Children is a medication designed to temporarily relieve cough caused by minor throat and bronchial irritation, 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 it can help clear mucus from your airways, making it easier to breathe and feel more comfortable.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a common cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This makes your coughs more productive, allowing you to clear out mucus more effectively.

Dosage and Administration

If you have a child aged 6 to under 12 years, you can give them 1 teaspoonful (15 mL) of the medication every 4 hours as needed. For children aged 2 to under 6 years, the dosage is 1/2 teaspoonful (7.5 mL) every 4 hours.

If your child is under 2 years old, it's important to consult your doctor before giving them this medication. Always ensure you follow these guidelines to help your child safely and effectively.

What to Avoid

You should avoid using this product if you have a persistent or chronic cough, such as from asthma or emphysema, especially if it comes with excessive mucus, unless your doctor advises otherwise. Additionally, do not give this product to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's Disease, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before use.

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 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 when using this product. If you develop a persistent cough that lasts more than a week, recurs, or is accompanied by fever, rash, or a lasting headache, you should consult your doctor, as this could indicate a serious condition.

Avoid using this product for chronic coughs associated with asthma or emphysema, or if your cough produces excessive mucus, unless directed by a healthcare professional. Additionally, do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication contains an MAOI, please check with a doctor or pharmacist before use.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health issues. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. If you suspect that you or someone else has taken too much, look for signs of an overdose, which may include unusual drowsiness, confusion, or difficulty breathing.

If an overdose occurs, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Remember, it's always better to be safe and get checked out if you have any concerns about a possible overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus. Use of this product should be avoided unless specifically directed by a healthcare provider.

If you do use this product, be aware that dosage adjustments may be necessary, so it's crucial to seek guidance from a healthcare professional. Additionally, keep an eye out for any adverse effects during your pregnancy and report them to your healthcare provider immediately. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When giving this medication to children, it's important to follow the correct dosage based on their age. For children aged 6 to under 12 years, the recommended dose is 1 teaspoonful (15 mL) every 4 hours. For those aged 2 to under 6 years, the dose is 1/2 teaspoonful (7.5 mL) every 4 hours. If your child is under 2 years old, you should consult your doctor before administering this medication.

Be cautious and avoid giving this product for persistent or chronic coughs, especially if your child has asthma or emphysema, or if the cough comes with a lot of mucus, unless directed by a doctor. Additionally, do not use this medication if your child is taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the last two weeks. Always keep the medication out of reach of children, and in case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 safety considerations and monitoring practices for patients with renal impairment (kidney issues) are not detailed.

It's always best to consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can help you understand how your kidney health may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how your treatment should be managed.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective, especially if you have any liver concerns. They can help determine the best approach for your health needs.

Drug Interactions

It's important to be cautious when considering this product for children, especially if they are taking certain medications. Specifically, you should not use this product if your child is on a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's Disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product.

If you're unsure whether your child's medication includes an MAOI, it's best to consult with a healthcare provider, such as a doctor or pharmacist. They can help ensure that your child's treatment is safe and effective. Always prioritize open communication about any medications or treatments your child is receiving.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15° to 30° C (59°-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. Taking these precautions will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Bisolvine Children used for?

Bisolvine Children temporarily relieves cough due to minor throat and bronchial irritation, such as that caused by the common cold, and helps loosen phlegm (mucus) to make coughs more productive.

What is the recommended dosage for children?

For children 6 to under 12 years of age, the dosage is 1 teaspoonful (15 mL) every 4 hours. For children 2 to under 6 years, it is 1/2 teaspoonful (7.5 mL) every 4 hours. Consult your doctor for children under 2 years.

Are there any contraindications for using Bisolvine Children?

Do not give this product for persistent or chronic cough, such as with asthma or emphysema, or if accompanied by excessive phlegm, unless directed by a doctor. It should not be used in children taking a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my child's cough persists?

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

Is Bisolvine Children safe to use during pregnancy?

The safety of Bisolvine Children during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

Can nursing mothers use Bisolvine Children?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk and the effects on nursing infants are not well studied.

What should I do in case of an accidental overdose?

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

How should Bisolvine Children be stored?

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

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 Children is identified by the SPL Code 34089-3. The insert does not provide specific details regarding the chemical name, physical characteristics, or inactive ingredients associated with this product.

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.

Dosage and Administration

For children aged 6 to under 12 years, the recommended dosage is 1 teaspoonful (15 mL) administered every 4 hours as needed.

For children aged 2 to under 6 years, the appropriate dosage is 1/2 teaspoonful (7.5 mL) every 4 hours as required.

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

Administration should be performed using a calibrated measuring device to ensure accurate dosing.

Contraindications

This product is contraindicated in the following situations:

Use is not recommended for patients with persistent or chronic cough, such as that associated with asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

This product should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare provider or pharmacist is advised before use.

Warnings and Precautions

Patients should not exceed the recommended dosage of this product. Adherence to the prescribed dosage is crucial to ensure safety and efficacy.

A persistent 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 indicated for use in cases of persistent or chronic cough, including those associated with asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare provider.

Caution is advised when administering this product to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's Disease. This product should not be given to such children or within two weeks of discontinuing an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a healthcare professional or pharmacist prior to administration.

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 persistent cough may indicate a serious underlying condition. Patients are advised to consult a healthcare professional if their cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms warrant immediate medical attention to rule out any serious health issues.

Drug Interactions

The use of this product is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's Disease. Additionally, this product should not be administered for a period of 2 weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to the administration of this product. It is essential to consult with a doctor or pharmacist if there is any uncertainty regarding the presence of an MAOI in the child's medication regimen.

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 aged 6 to under 12 years may be administered 1 teaspoonful (15 mL) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 1/2 teaspoonful (7.5 mL) every 4 hours. It is advised that children under 2 years of age consult a healthcare professional before use.

Caution is warranted in pediatric patients. This product should not be given for persistent or chronic cough, such as that associated with asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a physician. Additionally, this product must not be used in children who are taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Caregivers should verify with a healthcare provider or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

It is essential to keep this product out of reach of children. In the event of an accidental overdose, professional assistance should be sought immediately, or contact a Poison Control Center.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Use of this product should be avoided unless directed by a healthcare professional.

Dosage adjustments may be necessary for pregnant patients; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Additionally, special precautions should be taken to monitor for any adverse effects during pregnancy, and any such effects should be reported to a healthcare provider immediately.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage, which may manifest as a range of 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 the symptoms presented.

To prevent overdosage, strict adherence to the prescribed dosage guidelines is imperative. Healthcare professionals should educate patients about the importance of following the recommended dosage and the potential risks associated with exceeding it. Regular follow-up and monitoring can further mitigate the risk of overdosage and ensure patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients not to administer this product for persistent or chronic cough, such as that associated with asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a physician.

Additionally, it is important to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's Disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If there is any uncertainty regarding whether a child's prescription medication contains an MAOI, patients should be encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to administering this product.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 15° to 30° C (59° 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

No further data are available.

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.