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Budpak Baby Teething Oral Pain Reliever

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This product has been discontinued

Active ingredient
Benzocaine 7.5 g/100 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
December 26, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 7.5 g/100 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
December 26, 2013
Manufacturer
Budpak Inc.
Registration number
part356
NDC root
27293-015
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

This medication is designed to temporarily relieve sore gums in infants and children who are 4 months and older, particularly during the teething process. Teething can be uncomfortable for little ones, and this product aims to provide some comfort during that time.

If your child is experiencing discomfort from teething, this medication may help soothe their sore gums, making the process a little easier for both you and your child. Always consult with a healthcare professional for guidance on the best options for your child's needs.

Uses

If your child is experiencing sore gums from teething, this product can help provide temporary relief. It is suitable for infants and children who are at least 4 months old. You can use it to soothe their discomfort during this challenging time.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe option for your little one.

Dosage and Administration

Before using Budpak Baby Teething Gel Medicine, make sure the safety seal on the tube is intact. Start by washing your hands thoroughly to ensure cleanliness. Once your hands are clean, break the seal on the tube.

Using your fingertip or a cotton applicator, apply a small amount of the gel—about the size of a pea—to the area where your baby is experiencing discomfort. You can apply the gel up to four times a day, or follow any specific instructions given by your dentist or physician. If your infant is under 4 months old, it’s important to consult a doctor before using this product.

What to Avoid

It's important to use this medication responsibly. You should not use it for more than 7 days unless your doctor specifically instructs you to do so. Additionally, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. This will help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider.

Side Effects

If your baby has a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other "caine" anesthetics, it's important not to use this product.

You should stop using it and consult a dentist or physician if your baby’s sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists. Additionally, seek medical advice if swelling, a rash, or fever develops.

Warnings and Precautions

You should be aware that if your baby has a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, you should not use this product.

If you notice any signs of an overdose or an allergic reaction, it’s important to seek emergency medical help or contact a Poison Control Center immediately. Additionally, you should stop using the product and consult a dentist or physician if your baby's sore mouth symptoms do not improve within 7 days, if there is ongoing irritation, pain, or redness, or if any swelling, rash, or fever develops.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

It’s important to know that the safety of this product during pregnancy has not been established. If you are pregnant or planning to become pregnant, you should not use this product without first consulting your physician. Your healthcare provider can help you understand the potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during this time.

Lactation Use

If you are breastfeeding, you can use Budpak Baby Teething Oral Pain Reliever Gel without specific warnings or recommendations against it. Currently, there are no known concerns about this product being passed into breast milk or any associated risks for your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using new products while breastfeeding.

Pediatric Use

If your child is experiencing sore gums from teething, this product can help provide temporary relief for infants and children who are 4 months old and older. However, it is important to avoid using this product for infants younger than 4 months. If you have any questions or concerns about its use for your child, please consult your doctor for guidance.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication 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 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 be cautious when using this product, especially if your baby has a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. These "caine" anesthetics can cause serious allergic reactions, so you should avoid this product in such cases.

While there are no specific interactions with other drugs or laboratory tests mentioned, it's always a good idea to discuss any medications or tests with your healthcare provider. They can help ensure that everything you are using is safe and appropriate for your baby's health.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C and 25°C (59°F to 77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, please check that the tube safety seal is intact before use. If the seal is broken, do not use the product, as this may compromise its safety and effectiveness. Always follow these guidelines to ensure safe and proper use.

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 physician. Make sure to follow their instructions for the best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Budpak Baby Teething Gel used for?

Budpak Baby Teething Gel temporarily relieves sore gums due to teething in infants and children 4 months and older.

How should I apply Budpak Baby Teething Gel?

Wash your hands, break the seal on the tube, and use your fingertip or a cotton applicator to apply a small pea-size amount to the affected area up to 4 times daily or as directed by a dentist or physician.

Are there any contraindications for using this product?

Do not use Budpak Baby Teething Gel if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

What should I do if symptoms do not improve?

Stop using the gel and ask a dentist or physician if sore mouth symptoms do not get better in 7 days, or if irritation, pain, or redness persists.

Can I use Budpak Baby Teething Gel if my baby is under 4 months old?

No, do not use this product for infants under 4 months of age unless directed by a doctor.

What should I do in case of an overdose or allergic reaction?

Get emergency medical help or contact a Poison Control Center right away.

Is it safe to use Budpak Baby Teething Gel during pregnancy?

The safety of this product during pregnancy has not been established; consult a physician if pregnant or planning to become pregnant.

How should I store Budpak Baby Teething Gel?

Store the gel at 15°C to 25°C (59°F to 77°F) and do not use it if the tube safety seal is broken.

Packaging Info

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

Packaging configurations for Budpak Baby Teething Oral Pain Reliever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of sore gums associated with teething in infants and children aged 4 months and older.

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

Dosage and Administration

Healthcare professionals should ensure that the tube safety seal is intact before use. Prior to application, it is essential to wash hands thoroughly. After washing, the seal on the tube should be broken.

A small pea-sized amount of Budpak Baby Teething Gel Medicine should be applied to the affected area using either a fingertip or a cotton applicator. The gel may be applied up to four times daily, or as directed by a dentist or physician.

For infants under 4 months of age, it is advised to consult a doctor before administration.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used for more than 7 days unless directed by a physician. Additionally, it should not be used in excess of the recommended dosage.

Warnings and Precautions

The use of this product necessitates careful consideration of potential allergic reactions. It is imperative that healthcare professionals advise against its use in patients with a documented history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

In the event of an overdose or an allergic reaction, immediate medical assistance should be sought. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be advised to discontinue use and consult a dentist or physician if any of the following conditions occur: sore mouth symptoms that do not improve within 7 days, persistent irritation, pain, or redness, or the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning is that it should not be used in individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics.

In clinical practice, patients are advised to discontinue use and consult a dentist or physician if any of the following occur: sore mouth symptoms that do not improve within 7 days, persistent irritation, pain, or redness, or the development of swelling, rash, or fever. These symptoms may indicate a more serious condition that requires medical attention.

Drug Interactions

The use of this product is contraindicated in patients with a known history of allergy to local anesthetics, specifically those classified as "caine" anesthetics, including procaine, butacaine, and benzocaine.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Budpak Baby Teething Oral Pain Reliever.
Details

Pediatric Use

Pediatric patients aged 4 months and older may use this product to temporarily relieve sore gums associated with teething. It is important to note that this product is not recommended for infants under 4 months of age; healthcare professionals should be consulted for guidance in such cases.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should not use this product without first consulting a physician. Given the lack of established safety data, healthcare professionals are advised to carefully consider the potential risks and benefits before prescribing this product to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Budpak Baby Teething Oral Pain Reliever Gel in lactating mothers. Additionally, there are no statements concerning the potential for excretion of this product in breast milk or any associated risks to breastfed infants during the use of this product while nursing.

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

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose or allergic reaction.

Patients should be informed not to use the product for more than 7 days unless directed by a physician. It is important to emphasize that they should not exceed the recommended dosage.

Healthcare providers should counsel patients to discontinue use and consult a dentist or physician if sore mouth symptoms do not improve within 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if they experience irritation, pain, or redness that persists.

Patients should also be informed to discontinue use and consult a healthcare professional if they develop swelling, rash, or fever. It is crucial to explain that while using this product, fever and nasal congestion are not typical symptoms of teething and may indicate an underlying infection. If these symptoms do not resolve, patients should be encouraged to contact their physician.

Storage and Handling

The product is supplied in a tube format, with specific attention to the integrity of the packaging. It must be stored at a temperature range of 15°C to 25°C (59°F to 77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to inspect the tube prior to use; the product should not be utilized if the safety seal is broken, as this may compromise the product's safety and effectiveness.

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 Baby Teething Oral Pain Reliever, 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 Baby Teething Oral Pain Reliever, 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.

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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.