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Theragesic

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Active ingredients
  • Menthol 10 mg/1 g
  • Methyl Salicylate 150 mg/1 g
Other brand names
Dosage form
Cream
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
December 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 mg/1 g
  • Methyl Salicylate 150 mg/1 g
Other brand names
Dosage form
Cream
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
December 17, 2025
Manufacturer
Mission Pharmacal Company
Registration number
M017
NDC root
0178-0320
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 is a topical product designed to provide relief from discomfort in specific areas of the body. It comes in a convenient 3-ounce container, making it easy to apply directly to the skin. This product is formulated to maintain its therapeutic effects even after washing the area, ensuring you can enjoy a fragrance-free experience without losing its benefits.

While the specific mechanism of action isn't detailed, THERA-GESIC is intended for use in managing pain or discomfort, helping you feel more comfortable in your daily activities.

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 about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that there are no specific details regarding the dosage, administration, route, method, or frequency for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or use this medication safely and effectively. They will provide you with the necessary information tailored to your individual needs. Always follow their guidance to ensure the best outcomes for your health.

What to Avoid

You should avoid using this product if you have sensitive skin 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 comfort.

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

Side Effects

You should be aware that THERA-GESIC® 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 or heating pads. 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 THERA-GESIC® for children under 2 or between 2 and 12 years of age, you should first consult a doctor. Additionally, if you have a history of allergic reactions to aspirin or salicylates, please seek medical advice before using this product.

Warnings and Precautions

You should only use THERA-GESIC® on your skin and as directed. Avoid getting it in your eyes or on mucous membranes, and do not cover the treated area with bandages, wraps, or heating pads, nor should you recline on it after application.

If you notice any skin irritation or redness, stop using the product immediately. Remember, THERA-GESIC® is not meant to be swallowed. If you accidentally swallow it, seek medical help or contact a Poison Control Center right away. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, please consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

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 those between 2 and 12 years old who may be sensitive to aspirin or salicylate (a type of medication), it’s important to consult with a doctor. This ensures that the treatment is safe and appropriate for your child’s specific health needs.

For children aged 12 and older, you can apply a thin layer of the crème to the sore or painful area, but be sure not to exceed 3 to 4 applications in a day. Always follow your healthcare provider's guidance to ensure the best care for your child.

Geriatric Use

While there is no specific information about the use of THERA-GESIC (methyl salicylate cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it’s appropriate for you or your loved one, considering any individual health needs or conditions. Always prioritize safety and ensure that any new treatment fits well with existing medications or health issues.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with 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 kidney health. They can provide guidance tailored to your specific situation.

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, and there are no special monitoring requirements or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect it from light, so keep it in its original container and make sure that the container is tightly closed when not in use. Once you open the container, please remember to discard any remaining product after use to maintain safety and effectiveness.

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?

THERA-GESIC is a topical cream designed for external use to relieve soreness or pain.

How should I use THERA-GESIC?

Apply thin layers of the crème into and around the sore or painful area, not more than 3 to 4 times daily.

What should I do after applying THERA-GESIC?

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

Are there any precautions I should take?

Avoid contact with eyes or mucous membranes, and do not bandage, wrap, or use a heating pad after application.

What should I do if I experience skin irritation?

Discontinue use if skin irritation develops or redness is present.

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

If pregnant or breastfeeding, ask a health professional before use.

What should I do if I swallow THERA-GESIC?

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

What are the storage instructions for THERA-GESIC?

Store THERA-GESIC at 20-25°C (68-77°F) and keep the container tightly closed.

Who should not use THERA-GESIC?

Do not use if you are sensitive to oil of wintergreen (methyl salicylate) or on wounds or damaged skin.

What should I do if my condition worsens?

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 (methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theragesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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

There is currently no specific dosage and administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route of administration, and frequency of use. It is essential to consider individual patient factors and clinical judgment when determining the appropriate regimen.

Contraindications

Use 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 on wounds or damaged skin is contraindicated to prevent further irritation or complications.

The product should not be applied immediately after a shower or bath, as this may increase skin sensitivity. Swallowing the product is contraindicated, and the use of a heating pad after application of THERA-GESIC is also not recommended, as it may enhance absorption and increase the risk of side effects.

Warnings and Precautions

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

In terms of general precautions, users should discontinue use immediately if any skin irritation or redness develops. Ingestion of THERA-GESIC® is contraindicated; it should not be swallowed. Additionally, the application of a heating pad after using THERA-GESIC® is not recommended.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

Patients are advised to stop using THERA-GESIC® and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. No specific laboratory tests are required for monitoring during the use of this product.

Side Effects

Patients using THERA-GESIC® may experience a range of adverse reactions, which should be carefully monitored. The product is intended for external use only, and it is crucial to adhere strictly to the directions provided. Patients are advised to avoid contact with eyes or mucous membranes, and should not bandage, wrap, cover, use a heating pad after application, or recline upon skin treated with THERA-GESIC®.

In clinical practice, it is important to note that the product may produce a liquid sound upon shaking, which is a normal occurrence. However, patients should ensure that THERA-GESIC® does not come into contact with any surfaces other than skin. Additionally, the product should not be used if the tube is punctured.

Patients are instructed to stop using THERA-GESIC® and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For pediatric use, it is recommended that patients consult a doctor before using THERA-GESIC® in children under 2 years of age and in those aged 2 to 12 years. Furthermore, individuals who are prone to or have a history of allergic reactions to aspirin or salicylates should seek medical advice prior to using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Theragesic.
Details

Pediatric Use

Pediatric patients under 2 years of age and those between 2 to 12 years of age should consult a healthcare professional prior to use, particularly if they have a history of allergic reactions to aspirin or salicylates.

For children aged 12 years and older, the recommended application is to apply thin layers of the crème to the affected area up to 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of THERA-GESIC (methyl salicylate cream) 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 efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any adverse reactions or unexpected clinical presentations occur, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of skin irritation and allergic reactions associated with the use of THERA-GESIC®. Additionally, some users have experienced localized burning sensations upon application. There have been rare reports of systemic effects, including gastrointestinal discomfort and respiratory issues, in individuals sensitive to salicylates.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental poisoning. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the patient.

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) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply thin layers of the crème to the affected sore or painful area, ensuring that it is not used more than 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; if ingested, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Theragesic, 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, 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.