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Theraworx Pm Nighttime Maximum Strength Pain Relief

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
September 19, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
September 19, 2024
Manufacturer
AVADIM HOLDINGS, INC.
Registration number
M017
NDC root
61594-044
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 can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to manage your daily activities. If you're experiencing pain, this drug may provide the support you need to feel more comfortable.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities. There are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 2 years and older, apply a thin layer of the product to each affected area of your skin and let it air dry. You can repeat this process, but remember to wash your hands thoroughly after applying the product to avoid any unwanted contact with your eyes or mouth.

It's important not to use this medication more than 3 to 4 times a day. If you have a child under 2 years of age, do not use this product without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in large amounts, especially on raw or blistered skin, and be careful to keep it away from your eyes. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, you should stop using the product and consult a doctor.

If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this product. Additionally, keep it out of reach of children, and if swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. Be careful to keep it away from your eyes, as contact can cause irritation.

If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product. Always keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

When using this medication for children aged 2 years and older, you should shake the bottle well before applying a thin layer to the affected area. Allow it to air dry and repeat this process as needed, but do not apply it more than 3 to 4 times a day.

If your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize your child's safety and follow these guidelines carefully.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at temperatures between 32°F and 120°F. This range helps maintain the product's quality and performance.

When handling the product, remember that the package is designed to be child-resistant, so always replace the cap tightly after use to prevent accidental access. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, which means you will be putting it directly on your skin. For adults and children aged 2 years and older, roll a thin layer onto each affected area and let it air dry. Make sure not to use it more than 3 to 4 times a day. If you have any questions about how to use this medication, consult your healthcare provider for guidance.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. Children under 2 years of age should not use it without consulting a doctor.

How should I apply this drug?

Shake the bottle well, roll a thin layer to each affected area, and allow it to air dry. You can repeat this process, but do not use it more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with the eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or return after clearing up.

Is it safe to use this drug if I am pregnant or breastfeeding?

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

What should I do if this drug is swallowed?

Keep this drug out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store this drug?

Store the drug between 32°F and 120°F and ensure the cap is replaced tightly as the package is child-resistant.

Packaging Info

Below are the non-prescription pack sizes of Theraworx Pm Nighttime Maximum Strength Pain Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraworx Pm Nighttime Maximum Strength Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Theraworx Pm Nighttime Maximum Strength Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain. There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 2 years and older should shake the bottle well before use. A thin layer of the product should be rolled onto each affected area, allowing it to air dry. This application may be repeated as necessary, but it is important to wash hands thoroughly after applying the product. The maximum recommended frequency of application is 3 to 4 times daily.

For children under 2 years of age, the product is not recommended. Consultation with a healthcare professional is advised before use in this age group.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid applying it in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes during application. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is essential to discontinue use and consult a healthcare professional.

For individuals who are pregnant or breastfeeding, it is advisable to seek guidance from a health professional prior to use.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects. During use, patients should avoid contact with the eyes to prevent irritation or injury.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are instructed to stop use and consult a doctor.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product. Additionally, this product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Theraworx Pm Nighttime Maximum Strength Pain Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraworx Pm Nighttime Maximum Strength Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking the bottle well and applying a thin layer to each affected area, allowing it to air dry. The application may be repeated up to 3 to 4 times daily.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised prior to use.

Geriatric Use

There is no specific information 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

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 if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a child-resistant package. It is essential to ensure that the cap is replaced tightly after each use to maintain safety and integrity.

For optimal storage, the product should be kept within a temperature range of 32°F to 120°F. Proper handling and storage conditions are crucial to preserve the quality and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 2 years and older, a thin layer should be rolled onto each affected area, allowing it to air dry. The application should not exceed 3 to 4 times daily.

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 Theraworx Pm Nighttime Maximum Strength Pain 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 Theraworx Pm Nighttime Maximum Strength Pain 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.