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Little Colds Sore Throat Relief Melt Aways

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This product has been discontinued

Active ingredient
Benzocaine 6 mg
Other brand names
Dosage form
Granule
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2009
Label revision date
December 29, 2009
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 6 mg
Other brand names
Dosage form
Granule
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 2009
Label revision date
December 29, 2009
Manufacturer
Medtech Products Inc.
Registration number
part356
NDC root
63029-102
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Benzocaine is an oral anesthetic and analgesic that provides temporary relief from minor irritation, pain, sore throat, and sore mouth. Each packet contains 6 mg of benzocaine, which works by soothing the throat and relieving discomfort. This product, known as MEDICATED FOR KIDS 3 + LITTLE Colds® by Little Remedies, comes in a great-tasting grape flavor and is designed for easy use—no measuring or mixing is required, just straightforward relief.

Uses

You can use this medication for the temporary relief of occasional minor irritation, pain, sore throat, and sore mouth. It’s designed to help soothe these discomforts, making it easier for you to go about your day.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard. If you have any questions about how this medication can help you, feel free to ask your healthcare provider.

Dosage and Administration

To take this medication, start by emptying the entire contents of the packet directly onto your tongue. Allow the granules to dissolve completely before swallowing. For the best taste, avoid chewing the granules.

If you’re giving this medication to a child under 3 years old, it’s important to consult a doctor first. For children aged 3 to under 6 years, you can give 1 packet every 2 hours as needed. If the child is 6 years or older, they can take 1 to 2 packets every 2 hours as needed. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to follow the recommended dosage when using this medication. Exceeding the recommended amount can lead to serious health issues. Always use the medication as directed to ensure your safety and well-being. If you have any questions or concerns about your dosage, please consult your healthcare provider for guidance.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. Be aware that a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting, could indicate a serious condition, and you should consult a doctor immediately. It's important not to use this product for more than two days or give it to children under three years old unless directed by a healthcare professional.

You should stop using the product and consult a dentist or doctor if your sore mouth symptoms do not improve within seven days, or if you experience worsening irritation, pain, or redness. Additionally, if you notice swelling, a rash, or fever, seek medical advice. In the event of an overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Warnings and Precautions

You should avoid using this product if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other “caine” anesthetics. If you experience a severe or persistent sore throat, especially if it comes with a high fever, headache, nausea, or vomiting, it’s important to consult a doctor right away. Additionally, do not use this product for more than two days or give it to children under three years old unless directed by a doctor.

If your sore mouth symptoms do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, you should stop using the product and consult a dentist or doctor. Be alert for any swelling, rash, or fever, as these may require medical attention. In the event of an overdose or accidental poisoning, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose or accidental poisoning, 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 not typical for you.

Don’t wait to see if symptoms improve; prompt action can be vital. Always prioritize your health and safety by reaching out for professional assistance in these situations.

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 professional 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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when using this medication in children. You should avoid giving it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 3 to under 6 years, the recommended dosage is 1 packet every 2 hours as needed. If your child is 6 years or older, they can take 1 to 2 packets every 2 hours as needed. Always follow these guidelines to ensure your child's safety and well-being.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

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 (issues with liver function).

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 considering any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, or benzocaine (often ending in “caine”), you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 59–77°F (15–25°C). It's important to check the expiration date before use to guarantee its effectiveness.

When handling the product, be cautious of the packaging. If the foil packets are broken, do not use the product, as this indicates it may have been tampered with or compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other “caine” anesthetics, do not use this product. Be cautious if you experience a severe or persistent sore throat, especially if it comes with high fever, headache, nausea, or vomiting; in such cases, consult a doctor promptly. Avoid using the medication for more than two days or giving it to children under three years old unless directed by a 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 the event of an overdose or accidental poisoning, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Benzocaine used for?

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

How should I take Benzocaine?

Empty the entire contents of the packet onto your tongue, allow it to dissolve, and then swallow. For best taste, do not chew the granules.

What is the recommended dosage for children?

For children aged 3 to under 6 years, use 1 packet every 2 hours as needed. For children aged 6 years and over, use 1 to 2 packets every 2 hours as needed.

Are there any allergies I should be aware of?

Do not use Benzocaine if you have a history of allergy to local anesthetics such as procaine, butacaine, or other 'caine' anesthetics.

What should I do if my sore throat persists?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, consult a dentist or doctor.

Can I use Benzocaine if I am pregnant or breastfeeding?

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

What should I do in case of overdose?

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

What are the storage instructions for Benzocaine?

Store Benzocaine at 59–77°F (15–25°C) and do not use if the foil packets are broken.

Packaging Info

Below are the non-prescription pack sizes of Little Colds Sore Throat Relief Melt Aways (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Little Colds Sore Throat Relief Melt Aways.
Details

Drug Information (PDF)

This file contains official product information for Little Colds Sore Throat Relief Melt Aways, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Benzocaine is present at a concentration of 6 mg in each packet. It is a local anesthetic commonly used for its analgesic properties. The formulation is designed for topical application, providing targeted relief in the affected area.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation, pain, sore throat, and sore mouth.

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

Dosage and Administration

The entire contents of the packet should be emptied onto the tongue, allowing the granules to dissolve completely before swallowing. For optimal taste, it is advised not to chew the granules.

For patients under 3 years of age, consultation with a healthcare professional is recommended prior to administration. For children aged 3 to under 6 years, the recommended dosage is 1 packet every 2 hours as needed. For individuals aged 6 years and older, the dosage may be increased to 1 to 2 packets every 2 hours as needed.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

Patients with a known allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product. The risk of an allergic reaction in these individuals is significant and may lead to serious complications.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. The product should not be used for more than two days, and it is contraindicated for children under three years of age unless specifically directed by a physician.

Healthcare professionals should advise patients to discontinue use and seek consultation from a dentist or physician if sore mouth symptoms do not improve within seven days. Additionally, if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, medical advice should be sought immediately.

In the event of an overdose or accidental poisoning, it is crucial to obtain medical assistance or contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product due to the risk of serious allergic reactions.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. Patients experiencing these symptoms are advised to consult a doctor promptly. The product should not be used for more than 2 days, and it is contraindicated for children under 3 years of age unless directed by a healthcare professional.

Patients should discontinue use and seek advice from a dentist or doctor if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens. Additionally, if swelling, rash, or fever develops, medical consultation is recommended.

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

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of this product due to the potential for severe allergic reactions.

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 Little Colds Sore Throat Relief Melt Aways (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Little Colds Sore Throat Relief Melt Aways.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 3 to under 6 years, the recommended dosage is 1 packet every 2 hours as needed. In pediatric patients aged 6 years and older, the dosage may be increased to 1 to 2 packets every 2 hours as needed. Careful adherence to these guidelines is essential to ensure safety and efficacy in the pediatric population.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have 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 drug. Consequently, there are no 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 or accidental poisoning, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary widely depending on the substance involved and the individual patient’s condition.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers are advised to follow established protocols for overdose management, which may include decontamination procedures, administration of antidotes if applicable, and continuous monitoring of the patient’s vital signs and overall clinical status.

In summary, immediate action and appropriate medical intervention are critical in cases of overdose to ensure patient safety and effective management of the situation.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose or accidental poisoning. It is crucial for patients to understand the importance of adhering to the recommended dosage and to avoid exceeding it while using this product.

Patients should be informed to discontinue use and consult a dentist or doctor if sore mouth symptoms do not improve within 7 days. Additionally, they should be made aware that they need to seek medical advice if they experience persistent or worsening irritation, pain, or redness, or if they develop swelling, rash, or fever.

Storage and Handling

The product is supplied in tamper-evident foil packets. It is essential to inspect the packets prior to use; do not utilize any packets that are broken. The recommended storage temperature for the product is between 59–77°F (15–25°C). Additionally, users should verify the expiration date before using the product to ensure its safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients with a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, to avoid using this product. Patients experiencing severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should seek medical attention promptly. The product should not be used for more than two days or in children under three years of age unless directed by a healthcare professional. Pregnant or breastfeeding patients are encouraged to consult a healthcare professional before use. Additionally, it is important to keep the product out of reach of children and to seek immediate medical help or contact a Poison Control Center in the event of an overdose or accidental poisoning.

Drug Information (PDF)

This file contains official product information for Little Colds Sore Throat Relief Melt Aways, 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 Little Colds Sore Throat Relief Melt Aways, 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.