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Goyescas 7 Syrups

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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 2015
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 2015
Label revision date
October 19, 2015
Manufacturer
GOYESCAS OF FLA
Registration number
part346
NDC root
11856-5003
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 is a topical anesthetic that contains 5% benzocaine as its active ingredient. It is primarily used to provide temporary relief from minor irritation and pain in the mouth and throat, including discomfort caused by canker sores and minor injuries to the gums. By numbing the affected area, benzocaine helps alleviate soreness and protect irritated tissues, making it easier for you to eat and speak comfortably.

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 discomfort from minor irritations or injuries to the mouth and gums. Additionally, it provides protection for irritated areas in your sore mouth and throat, helping you feel more comfortable.

Dosage and Administration

When using 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 directs. 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, you should consult a doctor before using this product to make sure it’s appropriate for them. Always follow the guidance provided by your healthcare professional to achieve the best results.

What to Avoid

It's important to use this medication responsibly. Make sure you do not exceed the recommended dosage. If you experience a severe sore throat that lasts more than two days, or if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting, stop using the medication and consult your 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, please consult a healthcare professional before using this medication to ensure it is 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 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 suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in ensuring your safety and well-being.

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 a doctor before using the product. This will help you make sure it's appropriate for their specific needs. Always prioritize your child's safety and follow the recommended guidelines.

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 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 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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 feel free to ask questions and share your complete list of medications and tests to avoid any potential issues.

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 with clean hands and in a clean environment to maintain its integrity. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally, applying it to the affected area for at least one minute before spitting it out. Adults and children aged 2 years and older can use it up to four times a day, or as directed by your doctor. If the user is a child under 12 years old, they should be supervised during use. For children who are 2 years old, it's important to consult a doctor before use.

FAQ

What is Benzocaine used for?

Benzocaine is an anesthetic used for the temporary relief of occasional minor irritation, pain, sore mouth, and throat.

How should I use Benzocaine?

Apply Benzocaine 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.

What precautions should I take when using Benzocaine?

Keep Benzocaine out of reach of children, do not exceed the recommended dosage, and stop use if sore throat symptoms are severe or persist for more than 2 days.

Can I use Benzocaine if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

Are there any specific age recommendations for using Benzocaine?

Adults and children 2 years of age and older can use Benzocaine, but children under 12 should be supervised, and children 2 years of age should consult a doctor.

What are the storage instructions for Benzocaine?

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

Packaging Info

Below are the non-prescription pack sizes of Goyescas 7 Syrups (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goyescas 7 Syrups.
Details

Drug Information (PDF)

This file contains official product information for Goyescas 7 Syrups, 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.

This formulation is alcohol-free and is intended to be stored at room temperature, specifically between 68-77°F (20-25°C). Freezing is not recommended.

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 sore throat is severe, persists for more than 2 days, or 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 seek guidance from 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. Patients should not exceed the recommended dosage.

In clinical practice, patients are instructed to 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, patients should seek medical advice.

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

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Goyescas 7 Syrups (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Goyescas 7 Syrups.
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

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 clinical trials for 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 the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly in accordance with established medical protocols.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 assistance 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 discontinue use and consult a healthcare professional if they experience any of the following: severe sore throat, a sore throat that persists for more than two days, or if the sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. Additionally, patients should be advised to seek medical advice if sore mouth symptoms do not improve within seven days, or if irritation, pain, or redness persists or worsens.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a healthcare professional before using the medication to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 efficacy. 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 7 Syrups, 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 7 Syrups, 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.