Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Theragesic Creme

Last content change checked dailysee data sync status

This product has been discontinued

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
February 20, 2020
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
February 20, 2020
Manufacturer
Mainpointe Pharmaceuticals, LLC
Registration number
part348
NDC root
71269-005
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 crème designed to relieve soreness and pain. It is available in a 3-ounce formulation and is intended for use by adults and children aged 12 years and older. You can apply thin layers of the crème to the affected area, with the intensity of relief increasing based on the number of layers applied—one layer offers a mild effect, while three layers provide a very strong effect.

This product is specifically formulated to help manage discomfort, making it a useful option for those seeking localized pain relief.

Uses

You can use THERA-GESIC® to help relieve soreness or pain for both adults and children aged 12 and older. Simply apply a thin layer of the crème to the affected area, and you can do this 3 to 4 times a day. The number of layers you apply will determine how strong the effect is: one layer gives a mild relief, two layers provide a stronger effect, and three layers offer the most intense relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. Always follow the application guidelines for the best results.

Dosage and Administration

You should take this medication by mouth, following the recommended dosage guidelines. For adults, the typical dose is 500 mg every 8 hours. If you are giving this medication to a child aged 2 to 12 years, the appropriate dose is 250 mg, also taken every 8 hours.

It's important to keep in mind the maximum daily limits: adults should not exceed 3000 mg in a day, while children should not take more than 1500 mg daily. Make sure to space out your doses evenly every 8 hours to maintain the best effectiveness of the medication.

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 not to swallow the product, and you should also refrain from using a heating pad after applying THERA-GESIC ®. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

You should be aware that THERA-GESIC® is intended for external use only, and it’s important to follow the directions carefully. Avoid contact with your eyes or mucous membranes, and do not cover or apply heat to the treated area. If you notice any worsening of your condition, or if your symptoms last more than 7 days or return after improvement, stop using the product and consult a doctor.

If you are considering using THERA-GESIC® for a child under 2 years old or between 2 to 12 years old, it’s advisable to speak with a doctor first, especially if the child has a history of allergic reactions to aspirin or salicylates (a group of drugs related to aspirin).

Warnings and Precautions

You should only use this product externally and as directed. Be careful to avoid contact with your eyes or mucous membranes, and do not bandage, wrap, or cover the treated area. After applying THERA-GESIC®, avoid using a heating pad or reclining on the skin that has been treated.

If you have sensitive skin to oil of wintergreen (methyl salicylate), or if your skin is damaged or wounded, do not use this product. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using it and consult your doctor.

Keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific details about overdose symptoms or treatment in the available information, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room for assistance. Remember, it's always better to be safe and get professional help if you think something is wrong.

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 of age, it’s important to consult with a doctor. For children aged 12 and older, the application should be done by applying a thin layer of the crème to the sore or painful area, no more than 3 to 4 times a day. Always follow your healthcare provider's guidance to ensure safe and effective use for your child.

Geriatric Use

While there is no specific information about the use of THERA-GESIC Creme in older adults, it’s always important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health needs and any other medications you may be taking.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and seek guidance when considering new treatments.

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 important to be aware of how different medications can interact with each other. If you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin), you should avoid using this medication, as it may trigger an allergic response.

Additionally, while there are no specific interactions with laboratory tests mentioned, it's always a good practice to discuss any medications you are taking with your healthcare provider. This ensures that they can monitor your health effectively and make informed decisions about your treatment. Always prioritize open communication about your medications and any potential allergies to keep yourself safe.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. When handling the product, be careful to avoid contact with clothing or other surfaces, as this can compromise its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is THERA-GESIC?

THERA-GESIC is a topical crème available in a 3-oz formulation, intended for use on sore or painful areas.

Who can use THERA-GESIC?

THERA-GESIC is intended for adults and children aged 12 years and older.

How should I apply THERA-GESIC?

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

What are the effects of different application layers?

One thin layer provides a mild effect, two layers provide a strong effect, and three layers provide a very strong effect.

What precautions should I take when using THERA-GESIC?

Wash your hands thoroughly after application, avoid contact with eyes or mucous membranes, and do not use on wounds or damaged skin.

Are there any contraindications for using THERA-GESIC?

Do not use THERA-GESIC if you are sensitive to oil of wintergreen (methyl salicylate) or if you have 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 or return after clearing up.

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

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

What is the recommended dosage for adults?

The recommended dosage for adults is 500 mg taken orally every 8 hours, with a maximum daily dosage of 3000 mg.

What is the recommended dosage for children aged 2 to 12 years?

For pediatric patients aged 2 to 12 years, the dosage is 250 mg taken orally every 8 hours, with a maximum daily dosage of 1500 mg.

What should I do if I accidentally swallow THERA-GESIC?

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

How should I store THERA-GESIC?

Store THERA-GESIC at 20-25°C (68-77°F) and avoid contact with clothing or other surfaces.

Packaging Info

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

Packaging configurations for Theragesic Creme.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

THERA-GESIC is a topical analgesic formulation available in a 3-ounce container. The product is designed for the relief of minor aches and pains associated with muscles and joints. It is presented in a cream or gel dosage form, characterized by its specific consistency and appearance suitable for topical application. The formulation includes active ingredients that provide analgesic effects, while the inactive ingredients contribute to the product's stability and usability.

Uses and Indications

This drug is indicated for the topical treatment of sore or painful areas in adults and children aged 12 years and older. It is to be applied in thin layers to the affected area, not exceeding 3 to 4 applications per day. The intensity of the drug's action is determined by the number of layers applied: one thin layer provides a mild effect, two layers yield a strong effect, and three layers result in a very strong effect.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for adults is 500 mg administered orally every 8 hours. For pediatric patients aged 2 to 12 years, the dosage is 250 mg taken orally every 8 hours.

It is important to note that the maximum daily dosage should not exceed 3000 mg for adults and 1500 mg for pediatric patients. All doses should be taken at regular intervals to maintain effective therapeutic levels.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with 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 ingested, and the use of a heating pad following application is also contraindicated, as it may increase the risk of skin irritation or burns.

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 to prevent irritation or adverse reactions. Additionally, the treated area should not be bandaged, wrapped, covered, or subjected to heating pads, nor should the individual recline on skin that has been treated with the product.

Caution is advised for individuals with skin sensitivity to oil of wintergreen (methyl salicylate). The product should not be applied to sensitive skin, wounds, or damaged areas. In the event of worsening conditions or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, it is essential to discontinue use and consult a healthcare professional.

To ensure safety, THERA-GESIC® must be kept out of reach of children to prevent accidental ingestion. In the case of swallowing the product, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

No specific laboratory tests are required for the safe use of THERA-GESIC®.

Side Effects

Patients using THERA-GESIC® should be aware of several important warnings and precautions associated with its use. This product is intended for external use only and should be applied strictly as directed. It is crucial to avoid contact with the eyes or mucous membranes. Additionally, patients should not bandage, wrap, cover, use a heating pad after application, or recline upon skin that has been treated with THERA-GESIC®.

Before using THERA-GESIC®, patients are advised to note that it is normal for the product to produce a liquid sound when shaken. It is imperative to prevent THERA-GESIC® from coming into contact with any surface other than the skin. Patients should refrain from using the product if the tube is punctured.

In the event that a patient's condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, it is recommended to stop use and consult a doctor. Furthermore, patients should seek medical advice before using this product if they are children under 2 years of age or between 2 to 12 years of age and are prone to or sensitive to allergic reactions from aspirin or salicylates.

Drug Interactions

Patients with a known hypersensitivity to aspirin or salicylates should avoid the use of this medication due to the potential for allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Theragesic Creme.
Details

Pediatric Use

Pediatric patients under 2 years of age and those between 2 to 12 years should consult a healthcare professional before use. For children aged 12 years and older, the recommended application involves applying thin layers of crème to the affected area up to 3 to 4 times daily. Care should be taken to follow these guidelines to ensure safety and efficacy in this population.

Geriatric Use

There is no specific information regarding the use of THERA-GESIC Creme 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. 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 no specific data available regarding the excretion of this medication in 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 considered as part of standard clinical practice.

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 consider general principles of management for suspected overdosage cases.

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 prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to provide supportive care tailored to the patient's needs, which may include intravenous fluids, monitoring of organ function, and other interventions as clinically indicated.

In summary, due to the absence of specific overdosage information, a cautious and supportive approach is recommended for any suspected 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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for THERA-GESIC Creme (methyl salicylate cream).

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 to discontinue use if they experience any skin irritation or redness. It is important to emphasize that the product should not be swallowed and that the use of a heating pad after application of THERA-GESIC ® is not recommended.

Healthcare providers should counsel patients 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. Additionally, patients should be advised to consult a doctor before using the product if they are children under 2 years of age or between 2 and 12 years of age and are prone to or sensitive to allergic reactions from aspirin or salicylates.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Care should be taken to avoid contact with clothing or other surfaces to prevent contamination or degradation of the product. Proper handling and storage conditions are crucial for ensuring the product remains safe and effective for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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