Family Care Pain Relief

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children aged 12 years and older. Patients are advised to clean and dry the affected area prior to application. The drug should be applied generously to the affected area and massaged into the skin until thoroughly absorbed. This application may be repeated as necessary, not to exceed four times daily.

For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition.

• Concurrent use with a heating pad is not recommended, as it may lead to increased irritation or adverse effects.

• The product should not be used in individuals with known allergies to any of its ingredients to prevent allergic reactions.

• It is contraindicated for use in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. Individuals with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use to assess potential risks.

It is imperative to avoid application on wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. The product should not be used in conjunction with a heating pad, as this may increase the risk of burns or other complications. Additionally, individuals who are allergic to any of the product's ingredients must refrain from use. This product is not recommended for children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the presence of redness, irritation, or rash; worsening of the condition; or if symptoms persist beyond 7 days. Patients should also be informed that if symptoms resolve and then recur within a few days, they should consult their doctor.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware of the potential for allergic reactions, particularly if they have a history of sensitivity to aspirin or salicylates. It is advisable for these individuals to consult a healthcare professional prior to use.

In clinical practice, patients are advised to discontinue use and seek medical advice if they experience any of the following: the presence of redness, the development of irritation or rash, worsening of their condition, or if symptoms persist for more than 7 days. Additionally, if symptoms initially resolve and then recur within a few days, it is recommended that patients consult a doctor.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 Family Care Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients with arthritis-like conditions should not be treated with this medication if they are under 12 years of age. For children in this age group, it is essential to consult a healthcare professional before use.

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 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 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 regarding 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consider contacting a poison control center for guidance on the management of overdosage. It is crucial to document the incident thoroughly and report any adverse effects to the relevant regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of preventive measures, including patient education on the correct use of the medication and the importance of adhering to prescribed dosages.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that they should not use the product if they are allergic to any of its ingredients.

For pediatric patients, healthcare providers should emphasize that the product should not be used on children under 12 years of age who have arthritis-like conditions. Patients should be counseled to stop using the product and consult a doctor if they experience redness, irritation, or rash, or if their condition worsens or symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms resolve and then recur within a few days.

When using the product, patients should be reminded to follow the directions carefully and to avoid contact with the eyes, mucous membranes, or rashes. They should also be cautioned against applying a tight bandage over the area of application. It is recommended that patients discontinue use at least 1 hour prior to bathing or showering and avoid using the product immediately after bathing or showering. Lastly, patients should be encouraged to consult a doctor if there is any redness over the affected area before using the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care must be taken to protect the product from excessive heat to ensure its integrity and efficacy.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children aged 12 years and older should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; if ingested, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)