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Sore Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
June 19, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
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 2017
Label revision date
June 19, 2020
Manufacturer
ridge properties llc
Registration number
part348
NDC root
69804-075
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary for you. If you have specific information about a drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no mentions of teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that the information regarding the dosage and administration of the medication is not provided in the text. This means there are no specific instructions on how much of the medication you should take, how to prepare it, or how often you should use it.

For accurate dosage and administration details, it's important to refer to the accompanying image or consult your healthcare provider. They can give you the necessary guidance tailored to your individual needs. Always follow their instructions to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

While there are no specific side effects listed in the provided information, it's important to be aware that all medications can potentially cause adverse reactions. If you experience any unusual symptoms or reactions after taking a medication, it's advisable to consult your healthcare provider for guidance. Always stay informed about your treatment and communicate openly with your doctor about any concerns you may have.

Warnings and Precautions

It's important to be aware of certain warnings when using this medication. If you experience any unusual symptoms or side effects, you should stop taking the medication and call your doctor immediately. Additionally, if you have any concerns about your health or the medication's effects, don't hesitate to reach out to your healthcare provider for guidance.

While there are no specific general precautions or laboratory tests mentioned, it's always a good idea to discuss your complete medical history and any other medications you are taking with your doctor. This will help ensure that the treatment is safe and effective for you. If you ever feel that you need urgent medical assistance, seek emergency help right away. Your health and safety are the top priority.

Overdose

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

In case of an overdose, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. There are potential risks to the fetus, which is why its use is not recommended while you are pregnant. Always consult with your healthcare provider for guidance and to discuss any concerns you may have regarding medications during this time. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When considering this product for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children and adolescents) have not been determined. Therefore, you should consult with a healthcare professional before using this product for your child to ensure their safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. If your creatinine clearance (a measure of kidney function) is reduced, your healthcare provider will closely monitor your condition. Before starting treatment, and at regular intervals during your therapy, renal function tests will be performed to ensure your kidneys are handling the medication appropriately.

For those with moderate to severe renal impairment, a lower dose of the medication is recommended. Additionally, if you have end-stage renal disease, special care and consideration will be necessary to manage your treatment safely. Always communicate with your healthcare provider about your kidney health to ensure the best outcomes.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of the product.

Additional Information

No further information is available.

FAQ

What are the indications and usage for this drug?

No specific indications and usage details are provided.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What should I know about using this drug during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus.

Is this drug safe for pediatric use?

Pediatric use has not been established, and safety and effectiveness in pediatric patients have not been determined.

What precautions should I take if I have renal impairment?

Renal impairment may necessitate dosage adjustments, and patients with reduced creatinine clearance should be closely monitored.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, keep the container tightly closed, and discard after opening.

Are there any specific instructions for use or dosage?

No specific instructions for use or dosage are provided.

What should I do if I experience side effects?

No specific side effects are listed in the provided text.

Is there any information regarding nursing mothers?

There are no specific warnings or recommendations regarding nursing mothers or lactation.

What should I do if I have liver problems?

No specific information regarding hepatic impairment or precautions for patients with liver problems is provided.

Packaging Info

Below are the non-prescription pack sizes of Sore Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sore Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals are advised to refer to the accompanying image for comprehensive dosage and administration details. The image contains essential information regarding the specific dosing ranges, administration routes, methods, and frequency of administration. It is crucial to consult this visual reference to ensure accurate and effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

Warnings It is imperative to adhere to the specific warnings outlined in the product labeling. These warnings are designed to ensure patient safety and should be reviewed thoroughly prior to prescribing or administering the medication.

General Precautions While no specific general precautions are available, healthcare providers are encouraged to exercise clinical judgment and consider individual patient factors when prescribing this medication.

Laboratory Tests Currently, there are no recommended laboratory tests associated with the use of this medication. However, healthcare professionals should remain vigilant and monitor patients for any adverse effects or complications that may arise during treatment.

Emergency Medical Help In the event of a serious adverse reaction or emergency, it is crucial to seek immediate medical assistance. Healthcare providers should ensure that patients are informed about the signs and symptoms that warrant urgent care.

Discontinuation Instructions Patients should be advised to discontinue the medication and contact their healthcare provider if they experience any concerning symptoms or side effects. Clear communication regarding when to seek further medical advice is essential for patient safety.

Healthcare professionals are encouraged to maintain a proactive approach in monitoring their patients and providing guidance on the safe use of this medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. While no specific side effects have been detailed in the provided information, it is important for healthcare professionals to monitor patients for any unexpected reactions during treatment.

In clinical trials and postmarketing experiences, participants should be informed of the potential for adverse reactions, even if they are not explicitly listed. Continuous assessment and reporting of any new findings are essential to ensure patient safety and effective management of any emerging side effects.

Healthcare providers are encouraged to remain vigilant and to report any adverse reactions observed in patients to contribute to the ongoing evaluation of the medication's safety profile.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Sore Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sore Relief.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined.

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

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the benefits and risks when prescribing this medication to women of childbearing potential. It is essential to discuss alternative treatment options with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients receiving treatment. It is essential that patients with reduced creatinine clearance are closely monitored throughout their therapy. Prior to initiation of treatment, renal function tests should be performed, and these tests should be conducted periodically during the course of treatment to ensure ongoing safety and efficacy. For patients with moderate to severe renal impairment, a reduced dose is recommended to mitigate potential risks. Additionally, special consideration should be given to patients with end-stage renal disease, as their management may require further adjustments and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

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

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

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sore Relief, 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 Sore Relief, 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

Last AI update:

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.