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Goyescas Broncovac 5

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This product has been discontinued

Active ingredient
Benzocaine 50 mg/1 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 2006
Label revision date
October 19, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 50 mg/1 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 2006
Label revision date
October 19, 2015
Manufacturer
GOYESCAS OF FLA
Registration number
part346
NDC root
11856-5002
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

Benzocaine 5% is a topical anesthetic used to provide temporary relief from minor irritation and pain in the mouth and throat. It can help soothe discomfort caused by canker sores, minor injuries to the mouth and gums, and general soreness in these areas. By numbing the affected area, Benzocaine helps protect against further irritation and provides a sense of relief.

This medication is suitable for adults and children aged 2 years and older, and it is typically applied directly to the affected area for a short period. If you experience persistent or severe symptoms, it’s important to consult a healthcare professional for further advice.

Uses

You can use this medication for temporary relief from occasional minor irritation, pain, and soreness in your mouth and throat. It is effective for alleviating pain caused by canker sores and can help soothe minor irritation or injury to the mouth and gums. Additionally, it provides protection and comfort to irritated areas in your sore mouth and throat, making it easier for you to eat and speak.

Dosage and Administration

To use this medication, you should apply it to the affected area for at least one minute before spitting it out. This process can be done up to four times a day, or as your doctor advises. If you are using this product for a child under 12 years old, it's important that they are supervised during application to ensure safety and proper use.

If your child is 2 years old, please consult a doctor before using the product to get specific guidance tailored to their needs. Always follow the instructions provided by your healthcare professional to ensure the best results.

What to Avoid

It's important to use this medication responsibly. You should never exceed the recommended dosage. If you experience a sore throat that is severe, lasts more than two days, or is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting, stop using the medication and consult a doctor. Additionally, if your sore mouth symptoms do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, seek medical advice.

If you are pregnant or breastfeeding, it's essential to talk to a healthcare professional before using this medication to ensure it's safe for you and your baby.

Side Effects

It's important to be aware of potential side effects when using this medication. You should seek medical help immediately if you experience an overdose or if you notice severe symptoms such as a sore throat that lasts more than two days, especially if it's accompanied by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms in your mouth do not improve after a week, or if you experience worsening irritation, pain, or redness, you should stop using the medication and consult a doctor.

Always keep this medication out of reach of children and do not exceed the recommended dosage. If you are pregnant or breastfeeding, it's advisable to consult a healthcare professional before using this product.

Warnings and Precautions

Keep this medication out of the reach of children to ensure their safety. If you suspect an overdose, it’s important to seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and do not exceed it.

You should stop using this medication and consult your doctor if you experience a severe sore throat, if your sore throat lasts more than two days, or if it is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms in your sore mouth do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, reach out to your healthcare provider. If you are pregnant or breastfeeding, please consult a health professional before using this medication.

Overdose

If you think you or someone else may have taken too much of a medication, it’s important to get medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always follow the recommended dosage to avoid the risk of an overdose.

Remember, if you ever feel uncertain about the amount of medication taken, it’s better to be safe and seek assistance right away. Your health and safety are 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

When using this product for children, it's important to follow specific guidelines to ensure safety and effectiveness. For children aged 2 years and older, you can apply the product to the affected area for at least one minute before having them spit it out. This can be done up to four times a day or as directed by your doctor. However, if your child is under 12 years old, they should be supervised during use to ensure they are using it correctly.

If your child is only 2 years old, it's best to consult with your doctor before using the product. This extra step helps ensure that the treatment is appropriate for their specific needs. Always prioritize your child's safety and follow the recommended guidelines.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health concerns to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68-77°F (20-25°C). It's important to avoid freezing, as this can damage the product and affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should take this medication orally, applying it to the affected area for at least one minute before spitting it out. You can use it up to four times a day or as directed by your doctor. If you are using it for a child under 12 years old, make sure they are supervised. For children who are 2 years old, consult a doctor before use.

FAQ

What is Benzocaine 5% used for?

Benzocaine 5% is an anesthetic used for the temporary relief of occasional minor irritation, pain, sore mouth, and throat, including pain due to canker sores and minor injuries of the mouth and gums.

How should I use Benzocaine 5%?

Apply Benzocaine 5% to the affected area for at least one minute and then spit it out. You can use it up to 4 times daily or as directed by your doctor.

Are there any warnings I should be aware of?

Yes, keep Benzocaine 5% out of reach of children, do not exceed the recommended dosage, and stop use if sore throat is severe, persists for more than 2 days, or is accompanied by other symptoms like fever or rash.

What should I do in case of overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Can I use Benzocaine 5% if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Benzocaine 5%.

What are the storage instructions for Benzocaine 5%?

Store Benzocaine 5% at room temperature between 68-77°F (20-25°C) and do not freeze.

What age groups can use Benzocaine 5%?

Benzocaine 5% can be used by adults and children 2 years of age and older, but children under 12 should be supervised during use.

Packaging Info

Below are the non-prescription pack sizes of Goyescas Broncovac 5 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goyescas Broncovac 5.
Details

Drug Information (PDF)

This file contains official product information for Goyescas Broncovac 5, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Benzocaine 5% serves as the active ingredient in this formulation, functioning as a local anesthetic. The product contains several inactive ingredients, including benzalkonium chloride, eucalyptus oil, FD&C Red #40, propylene glycol, purified water, sodium bicarbonate, sodium borate, and sorbitol. It is designed to be stored at room temperature, specifically between 68-77°F (20-25°C). This formulation is also alcohol-free.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation, pain, and discomfort associated with sore mouth and throat. It is specifically indicated for pain due to canker sores, as well as pain resulting from minor irritation or injury of the mouth and gums. Additionally, this drug provides minor discomfort relief and protection for irritated areas in cases of sore mouth and sore throat.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area for a minimum of one minute, after which it should be expectorated. The application may be performed up to four times daily or as directed by a healthcare professional.

Children under 12 years of age must be supervised during the use of this product to ensure safe and effective application. For children aged 2 years, it is advised to consult a healthcare provider prior to use.

Contraindications

Use is contraindicated in the following situations:

  • Do not exceed the recommended dosage, as this may lead to adverse effects.

  • Discontinue use and consult a healthcare professional if severe sore throat persists for more than 2 days, or if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

  • If sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens, seek medical advice.

  • Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients not to exceed the recommended dosage, as doing so may lead to adverse effects.

Patients are instructed to discontinue use and consult a physician if any of the following conditions occur:

  • Severe sore throat.

  • Sore throat that persists for more than two days.

  • Sore throat accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

  • Symptoms of a sore mouth that do not improve within seven days.

  • Any irritation, pain, or redness that persists or worsens.

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

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of the reach of children. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately. To ensure safety, it is imperative not to exceed the recommended dosage.

Patients should discontinue use and consult a healthcare professional if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms related to a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use to ensure safety for both the patient and the child.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Goyescas Broncovac 5 (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goyescas Broncovac 5.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by applying it to the affected area for at least one minute before spitting it out. The product can be used up to four times daily or as directed by a healthcare professional.

For children under 12 years of age, supervision during use is recommended to ensure safety and proper application. Additionally, for pediatric patients specifically aged 2 years, consultation with a doctor is advised prior to use.

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 using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with excessive intake.

Healthcare professionals are advised to emphasize the importance of adhering to the recommended dosage guidelines. Exceeding the prescribed amount may lead to serious health complications, underscoring the necessity for vigilance in medication administration.

In summary, timely medical intervention and strict adherence to dosage recommendations are essential components in the management of overdose situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be cautioned not to exceed the recommended dosage of the medication. They should be informed to stop use and consult a doctor if they experience any of the following: severe sore throat, a sore throat that persists for more than two days, a sore throat accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, sore mouth symptoms that do not improve within seven days, or if irritation, pain, or redness persists or worsens.

Additionally, patients who are pregnant or breastfeeding should be advised to consult a healthcare professional before using the medication to ensure safety for themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, within the range of 68-77°F (20-25°C). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness. Proper handling and storage conditions must be adhered to in order to maintain the quality of the product.

Additional Clinical Information

The product is administered orally, with the recommended application for adults and children aged 2 years and older being to apply to the affected area for at least one minute before spitting it out. It may be used up to four times daily or as directed by a physician. For children under 12 years of age, supervision during use is advised, and consultation with a doctor is recommended for children aged 2 years.

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

Drug Information (PDF)

This file contains official product information for Goyescas Broncovac 5, 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 Goyescas Broncovac 5, 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.