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Budpak Oral Maximum Strength

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This product has been discontinued

Active ingredient
Benzocaine 0.2 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
June 8, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 0.2 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
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 2013
Label revision date
June 8, 2013
Manufacturer
Budpak Inc.
Registration number
part356
NDC root
27293-019
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

You may find this medication helpful for the temporary relief of pain associated with various conditions, including toothaches, canker sores, cold sores, fever blisters, and minor dental procedures. It is designed to provide you with comfort during these painful episodes, allowing you to manage discomfort effectively.

Uses

If you're experiencing pain from a toothache, canker sore, cold sore, fever blister, or after a minor dental procedure, this medication can provide you with temporary relief. It’s designed to help ease discomfort associated with these common oral issues, allowing you to feel more comfortable while you recover.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those in need of quick pain relief.

Dosage and Administration

You can use this medication to help with your condition by applying it directly to the affected area. For adults and children aged 2 years and older, you should apply it up to four times a day, or as your dentist or doctor advises. If you have a child under 12, make sure they are supervised while using the product to ensure safety.

For children younger than 2 years old, it's important to consult with a dentist or doctor before use, as there is no recommended dosage for this age group without professional guidance. Always follow the instructions provided by your healthcare provider to ensure the best results.

What to Avoid

If you are using this product, it's important to follow some key guidelines to ensure your safety and well-being. You should stop using it and consult a doctor if your sore mouth symptoms do not improve within 7 days, or if you experience swelling, rash, or fever. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice.

Be sure to avoid contact with your eyes, and do not exceed the recommended dosage. Following these instructions will help you use the product safely and effectively.

Side Effects

If you experience sore mouth symptoms that do not improve after 7 days, or if you develop swelling, a rash, or a fever, it's important to stop using this product and consult a doctor. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice.

Please remember not to use this product for more than 7 days unless directed by a dentist or doctor, especially if you have a history of allergies to local anesthetics like procaine or butacaine.

Warnings and Precautions

You should not use this product for more than 7 days unless your dentist or doctor specifically tells you to do so. If you have a history of allergies to local anesthetics, such as procaine or butacaine, it's important to avoid this product.

If your sore mouth symptoms do not improve after 7 days, or if you experience swelling, a rash, or fever, stop using the product and contact your doctor. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice.

In case the product is swallowed, you need to get emergency medical help right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

Currently, there is no information available about the use of Budpak Oral Maximum Strength benzocaine gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety. For children aged 2 years and older, you can apply the product to the affected area up to four times a day, or as directed by a dentist or doctor. However, if your child is under 12 years old, they should be supervised while using the product to prevent any misuse.

For children younger than 2 years, there is no recommended dosage unless a dentist or doctor provides specific advice and supervision. Always consult with a healthcare professional if you have any questions or concerns about using this product for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the safety and effectiveness of the product, store it at room temperature. You can find the lot number and expiration date printed on the crimp of the tube, so be sure to check this information regularly. It's important to keep this product, as well as all medications, out of the reach of children to prevent accidental ingestion.

If the product is swallowed, seek medical assistance or contact a Poison Control Center immediately. Taking these precautions will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, up to four times a day, or as directed by your dentist or doctor. Make sure to follow their instructions for the best results. If you have any questions about how to use the medication, don't hesitate to ask your healthcare provider for guidance.

FAQ

What is this product used for?

This product is used for the temporary relief of pain associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

How should I apply this product?

You should apply it to the affected area up to 4 times daily or as directed by a dentist or doctor.

Are there any age restrictions for using this product?

Children under 12 years of age should be supervised while using the product, and there is no recommended dosage for children under 2 years of age except under a dentist's or doctor's advice.

What should I do if my symptoms do not improve?

Stop using this product and ask a doctor if sore mouth symptoms do not improve in 7 days, or if swelling, rash, or fever develops.

Are there any warnings I should be aware of?

Do not use this product for more than 7 days unless directed by a dentist or doctor, and avoid it if you have a history of allergy to local anesthetics.

What should I do if I accidentally swallow this product?

If swallowed, get emergency medical help or contact a Poison Control Center right away.

Is this product safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or nursing, so consult your doctor for advice.

How should I store this product?

Store it at room temperature and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Budpak Oral Maximum Strength (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Budpak Oral Maximum Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a gel formulation intended for oral use, containing an unspecified active ingredient. It includes a range of inactive ingredients, which are not detailed in the provided information. The gel is packaged in unspecified packaging. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothache, canker sores, cold sores, fever blisters, and minor dental procedures.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to the affected area up to four times daily, or as directed by a dentist or physician. It is essential that children under 12 years of age are supervised during the use of this product to ensure safe and effective application. For children under 2 years of age, no recommended dosage is provided, and use should only occur under the guidance and supervision of a dentist or physician.

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a doctor under the following circumstances:

  • If sore mouth symptoms do not improve within 7 days.

  • If swelling, rash, or fever develops.

  • If irritation, pain, or redness persists or worsens.

  • If contact with the eyes occurs.

  • If the recommended dosage is exceeded.

Warnings and Precautions

The use of this product is subject to specific warnings and precautions to ensure patient safety and efficacy.

Duration of Use This product should not be used for more than 7 days unless directed by a dentist or a doctor. Prolonged use without professional guidance may lead to adverse effects.

Allergic Reactions Patients with a history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics, should avoid using this product due to the risk of severe allergic reactions.

Monitoring Symptoms Patients are advised to discontinue use and consult a healthcare professional if any of the following occur:

  • Symptoms of a sore mouth do not improve within 7 days.

  • Development of swelling, rash, or fever.

  • Persistence or worsening of irritation, pain, or redness.

Emergency Situations In the event of accidental ingestion, immediate medical assistance should be sought. Prompt intervention is critical to address potential complications associated with swallowing the product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to note that the product should not be used for more than 7 days unless directed by a dentist or a doctor.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience sore mouth symptoms that do not improve within 7 days. Additionally, the development of swelling, rash, or fever warrants immediate medical attention. Patients should also seek medical advice if they notice any irritation, pain, or redness that persists or worsens during treatment.

Furthermore, individuals with a history of allergy to local anesthetics, such as procaine, butacaine, or other "caine" anesthetics, should avoid using this product due to the risk of serious allergic reactions.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Budpak Oral Maximum Strength (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Budpak Oral Maximum Strength.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the product to the affected area up to 4 times daily or as directed by a dentist or doctor. For children under 12 years of age, supervision is recommended during the use of the product to ensure safety and proper application. In infants and children under 2 years of age, there is no recommended dosage unless advised and supervised by a dentist or doctor.

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

There is currently no information available regarding the use of Budpak Oral Maximum Strength benzocaine gel during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering its use in pregnant patients. Healthcare professionals are advised to exercise caution and consider the absence of data when prescribing this medication to women of childbearing potential. Further studies may be necessary to fully understand the implications of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed to discontinue use of the product and consult a doctor if symptoms of a sore mouth do not improve within 7 days. Additionally, they should be instructed to stop using the product and seek medical advice if they experience any swelling, rash, or fever.

It is important for healthcare providers to emphasize that patients should cease use and consult a doctor if they notice any irritation, pain, or redness that persists or worsens. Patients should also be cautioned to avoid contact with the eyes while using this product.

Finally, healthcare providers should remind patients not to exceed the recommended dosage to ensure safe and effective use of the product.

Storage and Handling

This product is supplied in a tube format, with specific lot numbers and expiration dates indicated on the crimp of the tube. It is essential to store the product at room temperature to maintain its efficacy.

Healthcare professionals should ensure that this product, along with all medications, is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

The medication is administered topically, with application to the affected area permitted up to four times daily or as directed by a dentist or physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Budpak Oral Maximum Strength, 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 Budpak Oral Maximum Strength, 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.