Stopain Extra Strength Continuous

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to apply the product directly onto the affected area. This should not exceed 3 to 4 times daily. It is important to wash hands thoroughly after each use to prevent unintentional contact with other areas of the body or with other individuals.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

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. Additionally, the product should not be applied to wounds or damaged skin to prevent potential complications and ensure safety.

Warnings and Precautions

For external use only, this product must be applied with caution to prevent adverse effects. Healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. The product is flammable; therefore, it should be kept away from fire or flame to prevent combustion. Additionally, the contents are under pressure; patients must be instructed not to puncture or incinerate the container and to avoid storing it at temperatures exceeding 120˚F.

It is imperative that the product is used only as directed. Patients should be cautioned against tightly bandaging the area of application or using a heating pad, as these practices may exacerbate skin irritation. Furthermore, the product should not be applied to wounds or damaged skin to prevent complications.

Patients should be 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. The presence of redness or excessive skin irritation also warrants immediate medical consultation.

In the event of accidental ingestion, patients must seek emergency medical assistance or contact a Poison Control Center without delay to ensure appropriate management.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. The product is intended for external use only, and contact with the eyes should be avoided. It is flammable; therefore, it must be kept away from fire or flame. Additionally, the contents are under pressure, and users should not puncture or incinerate the container. Storage should not exceed temperatures of 120˚F.

While using this product, it is crucial to follow the directions provided. Users should refrain from bandaging tightly or using a heating pad in conjunction with the product. It should not be applied to wounds or damaged skin.

Patients are advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or excessive skin irritation also warrants cessation of use and medical consultation.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Stopain Extra Strength Continuous (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a healthcare professional for guidance. For children aged 2 years and older, the medication may be applied directly to the affected area, with a recommended frequency of no more than 3 to 4 times daily.

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. 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 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

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 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. They should also be made aware that they should stop using the product if they experience redness or excessive irritation of the skin.

It is important to emphasize that patients should use the product only as directed. They should be cautioned against bandaging the area tightly or using a heating pad while using the product. Additionally, patients should be instructed not to apply the product to wounds or damaged skin to avoid further complications.

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 room temperature, ensuring that the storage environment does not exceed temperatures of 120˚F.

Due to its flammable nature, the product must be kept away from fire or flame to prevent any hazardous situations. Additionally, the contents are under pressure; therefore, it is critical to avoid puncturing or incinerating the container to ensure safety and integrity of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication directly to the affected area, with a maximum frequency of 3 to 4 times daily. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)