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Quality Choice Maximum Strength Oral Pain Relieving

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Benzocaine 200 mg/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 2019
Label revision date
August 9, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/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 2019
Label revision date
August 9, 2019
Manufacturer
Chain Drug Marketing Association Inc
Registration number
part356
NDC root
63868-477
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 be looking for a product designed to help with oral health, particularly for treating discomfort in the gums and teeth. This medication is suitable for adults and children aged 2 years and older, and it is applied directly to the affected area in the mouth.

While specific details about its mechanism of action or pharmacological properties are not provided, it is important to follow the usage instructions carefully, applying it as directed by a dentist or doctor. If you have any questions about its use or suitability for younger children, it's best to consult a healthcare professional.

Uses

You can use this product to help with oral care for both adults and children aged 2 years and older. Simply apply a small amount to the cavity and the gum area around the teeth, up to four times a day, or as your dentist or doctor advises. If you're using it for children under 12, make sure they are supervised during application. However, this product is not recommended for children under 2 years of age.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details on how to take or apply the medication, including the amount and frequency, are not provided.

If you have any questions or need guidance on how to use this medication, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized advice based on your health needs.

What to Avoid

It's important to use this medication safely. You should not use it for teething or in children under 2 years of age. Additionally, make sure to follow the dosage instructions carefully—do not use more than directed and do not use it for more than 7 days unless your doctor advises you to do so. Always prioritize your health and consult with a healthcare professional if you have any questions or concerns.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek medical help.

Additionally, if your child has a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, do not use this product. You should also consult a doctor if sore mouth symptoms do not improve after 7 days, or if you notice any irritation, pain, redness, swelling, rash, or fever.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child experiences symptoms such as pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

Additionally, if your child has a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, do not use this product. You should also stop using it and contact your doctor if sore mouth symptoms do not improve within 7 days, if irritation or pain worsens, or if you notice swelling, a rash, or fever. In case of an overdose, seek medical assistance or contact a Poison Control Center right away.

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 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 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

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

You should avoid using this product for children under 2 years of age. For children aged 2 years and older, it can be used, but it's important to supervise children under 12 while they use it. Be cautious if your child has a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other "caine" anesthetics, as this product may not be safe for them.

If you notice any signs of methemoglobinemia—a serious condition that can cause symptoms like pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, fatigue, or lack of energy—stop using the product immediately and seek medical help. Your child's safety is the top priority, so always follow these guidelines closely.

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 and safety considerations for patients with 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 and what steps to take for your safety.

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply this medication topically, up to four times a day, or as directed by your dentist or doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Always keep it out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the recommended use for adults and children 2 years of age and older?

You should remove the cap, cut the tip of the tube, and apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use it up to 4 times daily or as directed by a dentist or doctor.

Are there any age restrictions for using this product?

Yes, do not use this product in children under 2 years of age. Children under 12 years should be supervised while using it.

What should I do if I notice symptoms of methemoglobinemia?

Stop using the product and seek immediate medical attention if you or a child develops symptoms such as pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue.

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What should I do if sore mouth symptoms do not improve?

Stop using the product and consult a doctor if sore mouth symptoms do not improve within 7 days or if irritation, pain, or redness persists or worsens.

Is there an allergy alert for this product?

Yes, do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

What are the storage instructions for this product?

Store the product at room temperature between 20° to 25°C (68° to 77°F).

What should I do in case of overdose?

In cases of overdose, get medical help or contact a Poison Control Center right away.

Packaging Info

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

Packaging configurations for Quality Choice Maximum Strength Oral Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Quality Choice Maximum Strength Oral Pain Relieving, 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 text.

Uses and Indications

This drug is indicated for the topical treatment of oral cavity conditions in adults and children aged 2 years and older. It is to be applied as a small amount to the affected cavity and around the gums surrounding the teeth, with a maximum usage of up to four times daily or as directed by a dentist or physician.

Children under 12 years of age should be supervised during the application of this product to ensure safe and effective use. The use of this product is contraindicated in children under 2 years of age.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use is contraindicated in the following situations:

The product should not be used for teething. Additionally, it is contraindicated in children under 2 years of age due to safety concerns.

Patients should not exceed the directed dosage or use the product for more than 7 days unless specifically instructed by a healthcare professional.

Warnings and Precautions

The use of this product carries significant warnings and precautions that healthcare professionals must be aware of to ensure patient safety.

Methemoglobinemia Warning This product may induce methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. Symptoms can manifest even in patients who have previously used the product without issue. Immediate cessation of use and prompt medical attention are required if any of the following symptoms occur in the patient or a child under their care: cyanosis (pale, gray, or blue-colored skin), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Allergy Alert Healthcare professionals should advise against the use of this product in patients with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

Emergency Medical Help In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately.

Consultation with a Doctor Patients should be instructed to discontinue use and consult a healthcare provider if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens. Additionally, any development of swelling, rash, or fever warrants immediate medical evaluation.

These precautions are essential for the safe administration of the product and to mitigate potential adverse effects. Regular monitoring and patient education are recommended to ensure compliance and safety.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be advised to discontinue use and seek immediate medical attention if they or a child in their care experience symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy. It is important to note that methemoglobinemia can occur even in individuals who have previously used this product without incident.

Additionally, there is an allergy alert associated with this product. It should not be used in patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics.

Patients are also advised to stop use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens. Furthermore, if any swelling, rash, or fever develops, medical advice should be sought promptly.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Quality Choice Maximum Strength Oral Pain Relieving.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. It is indicated for use in adults and children aged 2 years and older. For children under 12 years of age, supervision during use is recommended to ensure safety.

Healthcare professionals should be aware of an allergy alert: this product should not be used in pediatric patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics.

In the event that a child develops symptoms of methemoglobinemia, such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue, or lack of energy, the product should be discontinued immediately, and medical attention should be sought.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. 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 may be advisable in 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 if the ingestion was recent.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use of this product.

The use of this product may lead to methemoglobinemia, a serious condition characterized by a reduction in the oxygen-carrying capacity of the blood. This condition can manifest even in individuals who have previously used the product without issue. Immediate medical attention should be sought if symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy occur in the user or in a child under their care.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to instruct patients not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless specifically directed by a healthcare professional.

Patients should be informed that this medication is not intended for use in teething and should not be administered to children under 2 years of age. They should be counseled to discontinue use and consult a doctor if symptoms of a sore mouth do not improve within 7 days. Additionally, patients should be advised to stop using the medication and seek medical advice if they experience any irritation, pain, or redness that persists or worsens, or if they develop swelling, a rash, or fever.

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, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and may be used up to four times daily or as directed by a dentist or doctor. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the product out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

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

Drug Information (PDF)

This file contains official product information for Quality Choice Maximum Strength Oral Pain Relieving, 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 Quality Choice Maximum Strength Oral Pain Relieving, 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.