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Theragesic Plus

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This product has been discontinued

Active ingredients
  • Menthol 40 mg/1 g
  • Methyl Salicylate 250 mg/1 g
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 1981
Label revision date
August 14, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 40 mg/1 g
  • Methyl Salicylate 250 mg/1 g
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 1981
Label revision date
August 14, 2019
Manufacturer
Mission Pharmacal Company
Registration number
part348
NDC root
0178-0350
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

THERA-GESIC® PLUS is a topical medication designed to provide relief from pain. It works by delivering therapeutic effects directly to the affected area, helping to alleviate discomfort. You can apply it to your skin, and even after washing the area, it will remain effective without leaving a fragrance. This makes it a convenient option for managing pain while maintaining your daily routine.

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 details regarding any potential 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, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

You should avoid using this product if your skin is sensitive to oil of wintergreen (methyl salicylate) or if you have any wounds or damaged skin. It's important to follow these guidelines to ensure your safety and the effectiveness of the product.

Additionally, do not apply it right before or after taking a shower or bath, and never swallow the product. After applying THERA-GESIC PLUS, avoid using a heating pad, as this can lead to unwanted effects. Always prioritize your health and safety by adhering to these instructions.

Side Effects

You should be aware that THERA-GESIC® PLUS is intended for external use only and should be applied as directed. Avoid contact with your eyes or mucous membranes, and do not cover the treated area with bandages, heating pads, or recline on it after application. If you notice any worsening of your condition, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

It's important to note that if you are considering using this product for children under 2 years old or between 2 to 12 years old, you should first consult a doctor. Additionally, if you have a history of allergic reactions to aspirin or salicylates, please seek medical advice before use. If the tube is punctured, do not use the product.

Warnings and Precautions

This product is for external use only, so please use it as directed and avoid contact with your eyes or mucous membranes. After applying THERA-GESIC PLUS, do not bandage, wrap, cover, use a heating pad, or recline on the treated skin. It's important to wait until after your shower or bath before using it, and avoid using it if your skin is sensitive to oil of wintergreen (methyl salicylate) or if you have wounds or damaged skin.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center immediately. You should stop using it and call your doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days.

Overdose

If you suspect an overdose, it's important to be aware that there may not be specific information available about the effects or treatment for this situation. However, you should always take any signs of overdose seriously. Common signs can include unusual drowsiness, confusion, or difficulty breathing (respiratory depression).

If you notice any of these symptoms or suspect an overdose, seek immediate medical help. It's crucial to contact your healthcare provider or go to the nearest emergency room right away. Remember, when in doubt, it's always better to err on the side of caution and get professional assistance.

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

Before using this medication for children under 2 years old or between 2 and 12 years old, it’s important to consult with a doctor. This ensures that the treatment is safe and appropriate for your child's specific needs. Always keep the medication out of reach of children to prevent accidental poisoning. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

For children aged 12 and older, you can apply a thin layer of the crème to the sore or painful area, but be sure to do this no more than 3 to 4 times a day. Following these guidelines will help ensure the safe use of the medication for your child.

Geriatric Use

When considering THERAGESIC PLUS (methyl salicylate gel) for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult who may need this medication, it’s wise to consult with a healthcare professional. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize safety and open communication with healthcare providers when managing medications for older adults.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 (issues with liver function).

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions to worry about. However, always ensure that your healthcare team is aware of all the medications and supplements you use, as this helps them provide the best care tailored to your needs.

By discussing your medications and any lab tests, you can help prevent potential issues and ensure that your treatment is as safe and effective as possible.

Storage and Handling

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

After opening, remember to discard any unused portion to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply a thin layer of the crème to the sore or painful area, doing this no more than 3 to 4 times a day. If you are pregnant or breastfeeding, it's important to consult a health professional before using this product. Additionally, keep it out of reach of children to prevent accidental poisoning. If the crème is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is THERA-GESIC® PLUS?

THERA-GESIC® PLUS is a topical medication used for pain relief.

How should I store THERA-GESIC® PLUS?

Store THERA-GESIC® PLUS at 20-25°C (68-77°F) and protect it from light.

What should I do after applying THERA-GESIC® PLUS?

You can shower or wash the area after application, which will leave it fragrance-free without reducing its therapeutic effect.

Are there any contraindications for using THERA-GESIC® PLUS?

Do not use THERA-GESIC® PLUS if your skin is sensitive to oil of wintergreen (methyl salicylate) or on wounds and damaged skin.

What precautions should I take when using THERA-GESIC® PLUS?

Avoid contact with eyes or mucous membranes, and do not bandage, wrap, or use a heating pad on the treated area.

What should I do if I experience skin irritation?

Discontinue use if skin irritation develops or if redness is present.

Can I use THERA-GESIC® PLUS if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using THERA-GESIC® PLUS.

What should I do if I swallow THERA-GESIC® PLUS?

If swallowed, get medical help or contact a Poison Control Center immediately.

How often can I apply THERA-GESIC® PLUS?

You can apply thin layers of THERA-GESIC® PLUS into and around the sore area up to 3 to 4 times daily.

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Packaging Info

Below are the non-prescription pack sizes of Theragesic Plus (methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theragesic Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

THERA-GESIC® PLUS is presented in a carton format, with the National Drug Code (NDC) 0178-0350-03.

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

No dosage and administration information was provided in the text.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known sensitivity to oil of wintergreen (methyl salicylate) should not use this product due to the risk of adverse skin reactions. Additionally, application is contraindicated on wounds or damaged skin, as this may exacerbate irritation or lead to further complications.

The product should not be applied immediately after showering or bathing, as this may affect its efficacy. Swallowing the product is contraindicated, and the use of a heating pad following application of THERA-GESIC PLUS is also not recommended, as it may increase the risk of skin irritation or burns.

Warnings and Precautions

For external use only, THERA-GESIC PLUS should be applied strictly as directed. It is imperative to avoid contact with the eyes or mucous membranes. Users must refrain from bandaging, wrapping, covering, using a heating pad after application, or reclining on skin treated with this product to prevent adverse effects.

General precautions must be observed to ensure safe usage. THERA-GESIC PLUS should not be applied immediately after showering or bathing, as this may increase the risk of skin irritation. Additionally, individuals with a known sensitivity to oil of wintergreen (methyl salicylate) should avoid using this product. It is also contraindicated for application on wounds or damaged skin to prevent further complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Side Effects

Patients using THERA-GESIC® PLUS may experience various adverse reactions, which should be carefully monitored.

Serious adverse reactions include the potential for allergic reactions, particularly in individuals who are sensitive to aspirin or salicylates. It is advised that patients consult a healthcare professional before using this product if they have a history of such sensitivities.

Common adverse reactions are primarily related to improper use of the product. Patients are cautioned that THERA-GESIC® PLUS is for external use only and should be applied strictly as directed. Contact with eyes or mucous membranes must be avoided to prevent irritation. Additionally, patients should refrain from bandaging, wrapping, covering, using a heating pad after application, or reclining on skin treated with the product, as these actions may exacerbate adverse effects.

In clinical practice, it is noted that patients may perceive a liquid sound upon shaking the product, which is a normal occurrence. However, it is crucial to ensure that THERA-GESIC® PLUS does not come into contact with any surfaces other than the skin to maintain its efficacy and safety.

Patients are advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, it is recommended that parents seek medical advice before using this product on children under 2 years of age or those between 2 and 12 years of age.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Theragesic Plus (methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theragesic Plus.
Details

Pediatric Use

Pediatric patients under 2 years of age and those between 2 to 12 years should consult a healthcare professional before use. It is essential to keep the product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For adolescents aged 12 years and older, the recommended application is to apply thin layers of crème into and around the affected area, not exceeding 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of THERAGESIC PLUS (methyl salicylate gel) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for 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 maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage cases. It is imperative to document the incident thoroughly and report any adverse effects to the appropriate regulatory authorities as per local regulations.

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

Serious adverse events have been reported voluntarily and through surveillance programs. For inquiries regarding serious adverse events or to obtain additional product information, individuals are encouraged to contact the designated support line at (210) 696-8400.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental poisoning. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to swallow the product and to discontinue use if they experience any skin irritation or redness. It is important to emphasize that patients should not use a heating pad after applying THERA-GESIC PLUS.

Healthcare providers should recommend that patients consult a doctor before using the product if they are children under 2 years of age or between 2 and 12 years of age. Additionally, patients should be advised to seek medical advice if they have a history of allergic reactions to aspirin or salicylates.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product 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).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Any unused portion should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommendation to apply thin layers of crème to the affected area up to 3 to 4 times daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the product out of reach of children to prevent accidental poisoning; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Theragesic Plus, 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 Theragesic Plus, 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.