Bluespring Doctors Pain Formula Pain Relief

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

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

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

Dosage and Administration

The medication should be applied to the affected area no more than three to four times daily. Healthcare professionals are advised to consult a physician prior to use in children under 12 years of age for arthritic conditions, and for all children under 2 years of age for any other indications.

Contraindications

Use is contraindicated in patients with wounded, damaged, or irritated skin due to the potential for exacerbation of the condition. Additionally, contact with eyes or mucous membranes should be avoided to prevent irritation or injury. Tight bandaging is also contraindicated, as it may lead to compromised circulation or increased local irritation.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounded, damaged, or irritated skin.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, it is advised not to apply a tight bandage over the treated area to prevent complications.

Users should discontinue use and consult a healthcare professional if a rash or any adverse reaction occurs. Furthermore, if the condition worsens or if symptoms persist beyond 10 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be obtained or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounded, damaged, or irritated skin. During use, patients are advised to avoid contact with eyes and mucous membranes, and to refrain from tightly bandaging the area of application.

In the event of a rash or any adverse reaction, patients should discontinue use and consult a healthcare professional. Additionally, if the condition worsens or symptoms persist for more than 10 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. Special caution is advised when considering use in children; a doctor should be consulted before application in children under 12 years of age if arthritis conditions are present, and for all other uses, a healthcare professional should be consulted before use in children under 2 years of age.

Patients should also ensure that the product is kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age with arthritis conditions should consult a doctor prior to use. For all other indications, it is advised that healthcare professionals be consulted before administering the product to children under 2 years of age. Additionally, the product should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication 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 regarding 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product to wounded, damaged, or irritated skin to prevent further complications.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience a rash or any adverse reaction. Additionally, patients should be cautioned to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days.

While using the product, patients must be reminded to avoid contact with the eyes and mucous membranes to prevent irritation. Furthermore, it is essential to advise patients against tightly bandaging the area where the product is applied, as this may lead to 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 3 or 4 times a day. Clinicians are advised to counsel patients regarding the use of the medication during pregnancy or breastfeeding, recommending that they consult a health professional before use. Additionally, it is important to consult a doctor before administering the medication to children under 12 years of age if arthritis conditions are present, and for all other listed uses, a consultation is necessary for children under 2 years of age.

Drug Information (PDF)

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

View product document (PDF)