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Extra Strength Pretat

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
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
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
June 19, 2020
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-019
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.

If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

To ensure you use this medication correctly, it's important to follow the detailed instructions provided in the accompanying image titled "Dosage and administration.jpg." This image contains all the necessary information regarding how to prepare and administer the medication.

While the specific route (how the medication is given), method, and frequency (how often you should take or apply it) are not included in the text, you can find this crucial information in the same image. Make sure to review it carefully to understand the best way to use the medication for your needs.

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.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. They can provide personalized advice and address any concerns you may have.

Side Effects

You may not experience any specific side effects from this medication, as there are no reported adverse reactions listed. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual, be sure to reach out for guidance.

Warnings and Precautions

It's important to be aware of certain warnings and precautions when using this medication. If you experience any severe side effects or unusual symptoms, you should seek emergency medical help immediately. Additionally, if you notice any concerning changes in your health or if your symptoms worsen, stop taking the medication and contact your doctor right away.

While specific laboratory tests and general precautions are not detailed here, it's always a good idea to discuss your medical history and any other medications you are taking with your healthcare provider. This will help ensure that the treatment is safe and effective for you.

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, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of this medication during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Due to potential risks to the fetus, using this medication while pregnant is not recommended.

If you are pregnant or think you might be, it’s best to discuss any medications you are taking with your healthcare provider to ensure the health and safety of both you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

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

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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 may 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 should I refer to for dosage and administration instructions?

Please refer to the image 'Dosage and administration.jpg' for detailed instructions.

Are there any contraindications for this drug?

There are no specific contraindications listed, but use is contraindicated in pregnancy due to potential risks to the fetus.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is contraindicated in pregnancy.

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and keep the container tightly closed.

Is there any information on pediatric use?

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

What should I do if I have questions about nursing mothers or lactation?

There are no specific statements regarding nursing mothers or lactation in the provided text.

Packaging Info

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

Packaging configurations for Extra Strength Pretat.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, 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 "A" on one side and "1" on the other side. Each tablet contains 1 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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 this information when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals are advised to refer to the image "Dosage and administration.jpg" for detailed instructions regarding the dosage and administration of the medication.

Specific information concerning the route, method, and frequency of administration is not included in the provided text. It is essential to consult the referenced image for comprehensive guidance on these aspects to ensure proper administration and patient safety.

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 critical warnings associated with the use of this medication. It is imperative to consult the specific warnings section for detailed information regarding contraindications and potential adverse effects.

In addition to the warnings, healthcare providers are advised to exercise caution when prescribing this medication. Regular monitoring of patient response and any emerging side effects is essential to ensure patient safety and therapeutic efficacy.

While specific laboratory tests have not been detailed, it is recommended that healthcare professionals consider appropriate monitoring parameters based on the patient's clinical status and the medication's pharmacological profile. This may include routine assessments relevant to the medication's effects and any potential complications.

In the event of severe adverse reactions or unexpected symptoms, immediate medical assistance should be sought. Patients should be instructed to discontinue use of the medication and contact their healthcare provider if they experience any concerning side effects.

Side Effects

There are no specific adverse reactions or side effects listed in the provided data. As such, no additional information regarding serious or common adverse reactions, clinical trial insights, or postmarketing experiences is available for inclusion. It is important for healthcare professionals to monitor patients for any unexpected reactions and report them as necessary.

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 Extra Strength Pretat (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Pretat.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined. Therefore, caution is advised when considering this product for use in children, infants, or adolescents.

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.

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 statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions indicated 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 consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 safety profile 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 necessity of proper storage to ensure the safety of young individuals.

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. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, 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 Extra Strength Pretat, 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.