Pain Relief

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 associated with muscles and joints, including conditions such as simple backache, strains, 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 the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging the area tightly or using it in conjunction with a heating pad. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Patients may experience a transient burning sensation upon application; however, this typically resolves within several days. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Patients should be instructed to stop using the product and contact their healthcare provider if any of the following occur: worsening of the condition, blistering or burning sensations, pain or swelling, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients may experience a transient burning sensation upon application of the product, which typically resolves within several days. However, if a severe burning sensation occurs, it is advised to discontinue use immediately.

Patients should also stop using the product and consult a healthcare professional if any of the following occur: worsening of the condition, blistering or burning sensations, pain or swelling, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These reactions warrant medical attention to ensure patient safety and appropriate management.

Drug Interactions

There are currently no documented drug interactions associated with 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 Pain Relief (menthol 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3-4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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 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

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the individual and the circumstances surrounding the event. In cases where an overdose is suspected, immediate medical attention is warranted.

Recommended actions include contacting a poison control center or seeking emergency medical assistance. It is crucial to monitor the patient closely for any adverse effects and to initiate supportive care as necessary.

Management procedures may involve symptomatic treatment and monitoring of vital signs, as well as any specific interventions based on the clinical presentation.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, there was no increase in fetal malformations noted in these studies. The available data do not indicate any concerns regarding teratogenicity or non-teratogenic effects in the context of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a configuration suitable for external use only. It is essential to store the product at room temperature, ensuring it is kept away from fire or flame to maintain safety and efficacy.

Care should be taken to avoid contact with eyes and mucous membranes. The product must not be applied to wounds or any damaged, broken, or irritated skin. Additionally, it is important not to bandage the area tightly or use the product in conjunction with a heating pad.

Once opened, the product should be discarded to prevent any potential contamination or degradation.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3-4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use. Clinicians should counsel patients to seek medical assistance or contact a Poison Control Center immediately if the product is accidentally ingested.

Drug Information (PDF)

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

View product document (PDF)