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Family Dollar

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
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 2013
Label revision date
June 13, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
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 2013
Label revision date
June 13, 2023
Manufacturer
Family Dollar Services Inc.
Registration number
part356
NDC root
55319-388
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

FAMILY WELLNESS Oral Pain Relief is a liquid anesthetic that contains 20% benzocaine, designed to provide temporary relief from pain associated with various mouth and gum irritations. This product can help soothe discomfort caused by conditions such as toothaches, sore gums, canker sores, braces, and minor dental procedures.

When you use FAMILY WELLNESS Oral Pain Relief, the benzocaine works by numbing the affected area, which can help you feel more comfortable during times of oral discomfort.

Uses

If you're dealing with discomfort in your mouth or gums, this medication can help provide temporary relief. It's effective for various issues, including toothaches, sore gums, canker sores, and discomfort caused by braces or minor dental procedures.

Using this medication can make it easier for you to manage these irritations, allowing you to feel more comfortable while you go about your day. Remember, it's designed specifically for short-term relief, so be sure to follow any guidance from your healthcare provider regarding its use.

Dosage and Administration

When using this medication, you should apply it directly to the affected area using the applicator tip. For adults and children aged 2 years and older, you can use it up to four times a day, or as your dentist or doctor advises. If you are applying it for a child under 12 years old, make sure they are supervised during use to ensure safety.

It's important to note that this product is not recommended for children under 2 years of age, so please avoid using it for that age group. Always follow the guidance provided by your healthcare professional to ensure the best results.

What to Avoid

You should avoid using this medication in children under 2 years of age. It's important to follow the dosage instructions carefully: do not use more than directed and do not use it for more than 7 days unless your dentist or doctor advises you to do so. Additionally, this medication should not be used for teething. Always prioritize safety and consult 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 attention.

You should also avoid this product if you have a known allergy to local anesthetics like procaine, butacaine, or benzocaine. If you notice swelling, rash, or fever, or if irritation, pain, or redness persists or worsens, contact your doctor. Additionally, if symptoms do not improve within 7 days or if you experience any allergic reactions, seek medical advice. In case of overdose, get medical help or contact a Poison Control Center right away.

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've used it before. If you or a child experiences symptoms like 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.

You should avoid this product if you have a known allergy to local anesthetics, such as procaine, butacaine, or benzocaine. Additionally, if you notice swelling, rash, or fever, or if irritation, pain, or redness continues or worsens, stop using the product and consult your doctor. If your symptoms do not improve within 7 days or if you experience any allergic reactions, reach out to your healthcare provider. In case of an overdose, seek medical assistance or contact a Poison Control Center right away.

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 typical side effects.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and well-being by reaching out for professional assistance in these situations.

Pregnancy Use

It’s important to be cautious if you are pregnant or planning to become pregnant. The safety of this product during pregnancy has not been evaluated, and its use is not recommended due to potential risks to your developing baby. Specifically, there may be risks associated with the use of benzocaine, which could affect the fetus.

Before using this product, it’s essential to consult with your healthcare provider. They can provide guidance tailored to your situation and help you make informed decisions about your health and the health of your baby.

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. Additionally, there are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

This product should not be used in children under 2 years of age. For children aged 2 years and older, you can apply it to the affected area using the applicator tip, up to four times a day or as directed by a dentist or doctor. If your child is under 12, it's important to supervise their use of this product.

Be sure to stop using it and consult a doctor if your child experiences swelling, rash, or fever, if irritation, pain, or redness persists or worsens, if symptoms do not improve within 7 days, or if any signs of an allergic reaction occur.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for determining the right approach for you. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 help you understand how to manage your treatment effectively while considering your kidney health.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be aware of potential interactions when using this product. If you have a history of allergies to local anesthetics, such as procaine, butacaine, or benzocaine (often ending in “caine”), you should avoid this product. Additionally, this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood and requires immediate medical attention.

Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being. They can help you understand any risks and make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, always store it in a cool, dry place at a temperature between 20 - 25°C (68-77°F). It's important to keep the package sealed and unopened until you are ready to use it. If the package has been opened, do not use the product, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it works as intended.

Additional Information

You should take this medication orally, applying it to the affected area using the applicator tip. For adults and children aged 2 years and older, you can use it up to four times a day or as directed by your dentist or doctor. If you are supervising a child under 12 years of age, make sure to oversee their use of the product. It is important to note that this medication should not be used by children under 2 years old.

FAQ

What is FAMILY WELLNESS Oral Pain Relief?

FAMILY WELLNESS Oral Pain Relief is a liquid anesthetic containing 20% benzocaine, designed to temporarily relieve pain associated with mouth and gum irritations.

What conditions can this product treat?

It can treat toothache, sore gums, canker sores, discomfort from braces, and pain from minor dental procedures.

Who can use this product?

Adults and children 2 years of age and older can use it, but children under 2 years of age should not use it.

How should I use FAMILY WELLNESS Oral Pain Relief?

Apply to the affected area using the applicator tip, up to 4 times daily or as directed by a dentist or doctor.

Are there any warnings associated with this product?

Yes, it may cause methemoglobinemia, a serious condition that reduces oxygen in the blood. Seek immediate medical attention if you notice symptoms like pale skin, headache, or shortness of breath.

What should I do if I experience an allergic reaction?

Stop using the product and seek medical advice if you develop swelling, rash, or fever, or if irritation persists.

Is it safe to use during pregnancy?

The product has not been evaluated for safety during pregnancy, and its use is not recommended due to potential risks to the fetus.

What should I do in case of overdose?

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

How should I store this product?

Store at 20 - 25°C (68-77°F) and do not use if the package has been opened.

Packaging Info

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

Packaging configurations for Family Dollar.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Benzocaine is a liquid anesthetic formulation containing 20% benzocaine as the active ingredient. It is presented in a volume of 0.5 fluid ounces (14.7 mL). This formulation is designed for local anesthesia applications.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with various mouth and gum irritations, including toothache, sore gums, canker sores, discomfort from braces, and pain resulting from minor dental procedures.

There are no 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 using the applicator tip. The recommended frequency of application is up to four times daily, or as directed by a dentist or physician. It is advised that children under 12 years of age be supervised during the use of this product to ensure safe and effective application.

The product is not recommended for use in children under 2 years of age.

Contraindications

Use is contraindicated in children under 2 years of age.

Additionally, the product should not be used for more than 7 days unless directed by a dentist or doctor, and it is not indicated for teething. Use beyond the recommended duration or for unapproved indications may pose risks to patient safety.

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 incident. Immediate cessation of use and prompt medical attention are imperative 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 Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product due to the risk of severe allergic reactions.

Monitoring and Follow-Up Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following conditions arise: swelling, rash, or fever; persistent or worsening irritation, pain, or redness; lack of improvement in symptoms after 7 days; or any signs of an allergic reaction.

Overdose Management In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance. Prompt intervention is essential to mitigate potential adverse effects.

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. This serious condition can occur even in patients who have previously used the product without issue. Patients should 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.

Additionally, there is an allergy alert associated with this product. Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product.

Patients are advised to stop use and consult a healthcare professional if they develop swelling, rash, or fever; if irritation, pain, or redness persists or worsens; if symptoms do not improve within 7 days; or if any allergic reaction occurs.

In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The use of this product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics. Patients with such a history should avoid this product to prevent potential allergic reactions.

In addition, the product carries a warning regarding the risk of methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This condition requires immediate medical attention if it occurs. Healthcare professionals should monitor patients for signs of methemoglobinemia, particularly in those who may be at higher risk. Prompt recognition and treatment are essential to mitigate the effects of this condition.

Packaging & NDC

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

Packaging configurations for Family Dollar.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. For children aged 2 years and older, the product is to be applied to the affected area using the applicator tip, with a maximum frequency of up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age should be supervised during the use of this product. Healthcare professionals should advise caregivers to discontinue use and consult a doctor if any of the following occur: swelling, rash, or fever develops; irritation, pain, or redness persists or worsens; symptoms do not improve within 7 days; or an allergic reaction occurs.

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

The product has not been evaluated for safety during pregnancy. Use is not recommended during pregnancy due to potential risks to the fetus associated with the use of benzocaine. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Postmarketing experience has revealed cases of methemoglobinemia associated with the use of benzocaine products. These cases have been reported in patients who have previously used the product without issue, indicating that methemoglobinemia can occur even in individuals with prior tolerance to benzocaine.

Patient Counseling

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

Patients should be cautioned not to exceed the recommended dosage and to refrain from using the medication for more than 7 days unless directed by a dentist or doctor. It is important to inform patients that this medication is not intended for use in teething.

Providers should emphasize that the medication should not be used in children under 2 years of age. Patients should be instructed to stop use and consult a doctor if they experience swelling, rash, or fever. Additionally, if irritation, pain, or redness persists or worsens, patients should seek medical advice.

Patients should also be informed to discontinue use and contact a healthcare professional if their symptoms do not improve within 7 days or if they experience any signs of an allergic reaction.

Storage and Handling

The product is supplied in a package that must not be used if it has been opened. It should be stored at a temperature range of 20 to 25°C (68 to 77°F) to ensure its integrity and efficacy. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The product is administered orally, with the recommended application method for adults and children aged 2 years and older being to apply to the affected area using the applicator tip. It may be used up to four times daily or as directed by a dentist or doctor. It is advised that children under 12 years of age be supervised during use, and the product is not recommended for children under 2 years of age.

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 Family Dollar, 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 Family Dollar, 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.