Extra Strength Pain Relief Therapy

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of symptoms in adults and children aged 12 years and older. It is recommended for use up to 8 hours and no more than three times a day. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may lead to adverse effects. Additionally, application to wounds or damaged skin is prohibited to prevent potential complications.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center or seeking emergency medical help.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be advised to stop use and seek medical advice if any redness or skin irritation develops during treatment.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, individuals should seek medical advice if redness is present or if skin irritation develops.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 medication in human 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 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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in 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 in these areas limits the understanding of the compound's potential effects 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 product out of reach of children. 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 stop using the product and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days or clear up and then recur within a few days, redness is present, or if skin irritation develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. Additionally, patients should be cautioned to avoid contact with the eyes and mucous membranes, and to refrain from applying 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 should advise patients who are pregnant or breastfeeding to consult a healthcare professional 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)