Extra Strength Pain Relief Therapy

Description

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for use in adults and children aged 12 years and older. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

There is currently no dosage and administration information available for the product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the potential for increased sensitivity or adverse reactions.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, recurrence of symptoms after resolution within a few days, or the presence of redness or skin irritation.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: conditions worsen, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or skin irritation develops. These warnings are essential to ensure patient safety and to address any potential adverse reactions effectively.

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 dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pain Relief Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the product is applied by peeling off the protective backing and adhering the sticky side to the affected area. It is indicated for use for up to 8 hours and should not be applied more than 3 times a day.

It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or unexpected reactions, particularly in cases of suspected overdose.

Should an overdosage occur, the following general recommendations should be considered:

Monitoring and Assessment Healthcare providers should conduct a thorough assessment of the patient’s clinical status. Vital signs should be monitored regularly, and any symptoms indicative of overdosage should be documented.

Symptom Management While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for common signs associated with excessive dosing of similar medications. These may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Supportive Care In the event of an overdosage, supportive care is paramount. This may involve intravenous fluids, electrolyte management, and symptomatic treatment as necessary.

Consultation with Poison Control It is advisable to contact a poison control center or a medical toxicologist for guidance on the management of suspected overdosage cases. They can provide specific recommendations based on the clinical scenario and the medication involved.

Documentation and Reporting All instances of overdosage should be documented in the patient's medical record, and appropriate regulatory bodies should be notified as per local guidelines.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to manage potential cases with appropriate monitoring, supportive care, and consultation with specialists.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens. Additionally, they should be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if any redness is observed. It is also important to inform patients to stop use and consult a healthcare professional if they experience any skin irritation.

When discussing the application of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned against bandaging the area tightly or using a heating pad while using the product. Furthermore, they should be advised to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin.

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 room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied for a maximum duration of 8 hours, not exceeding three applications per day. Clinicians are advised to counsel patients to consult a health professional if they are pregnant or breastfeeding prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)