Dr Paines Pain Relief

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The medication should be applied to the affected area no more than three to four times daily. For adults and children aged two years or older, it is recommended to consult a physician prior to use. In the case of children under two years of age, consultation with a physician is also advised before application.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, it is essential to seek medical advice promptly. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, care should be taken to avoid tight bandaging of the area where the product is applied, as this may affect its efficacy and safety.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with their physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. If swallowed, patients should seek medical advice immediately.

It is important to note that the product should not be applied to wounds or damaged skin, and patients should refrain from bandaging the area tightly after application.

For pregnant or breastfeeding individuals, it is recommended to contact a physician prior to use to ensure safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under two years of age should consult a physician prior to use. For children and adolescents aged two years and older, it is also recommended to consult a physician before administration.

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 contact their physician prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

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 this drug. 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 prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. Therefore, it is crucial for healthcare providers to assess the patient's condition thoroughly and monitor for any adverse effects that may arise.

Management of overdosage should be guided by the severity of symptoms and the clinical judgment of the healthcare professional. Supportive care and symptomatic treatment may be necessary, and further medical intervention should be considered based on the patient's response and any complications that may develop.

In all cases of suspected overdosage, prompt consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management and care.

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 text.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to instruct patients to apply the product only to wounds or damaged skin, ensuring that it is used appropriately to avoid complications. Additionally, patients should be informed not to bandage the area tightly after application, as this could impede proper healing and increase the risk of adverse effects.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients should apply the medication to the affected area no more than three to four times daily. Clinicians should advise patients to discontinue use and consult a physician if symptoms persist for more than seven days. Additionally, patients who are pregnant or breastfeeding are encouraged to contact their physician prior to use.

Drug Information (PDF)

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

View product document (PDF)