K19 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 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

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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or adverse reactions. In the event that symptoms persist for more than 7 days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, immediate consultation with a physician is advised. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, it is important to avoid tightly bandaging the area of application to ensure proper air circulation and to prevent skin irritation.

Healthcare professionals should advise patients who are pregnant or breastfeeding to contact their physician prior to use to ensure safety for both the mother and child.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with eyes and mucous membranes. In the event that symptoms persist for more than 7 days, it is advised to discontinue use and consult a physician.

It is crucial to keep the product out of reach of children. If swallowed, patients should seek medical advice immediately. The product should not be applied to wounds or damaged skin, and it is recommended not to bandage the area tightly after application.

For pregnant or breastfeeding individuals, it is important to contact a physician prior to use to ensure safety and appropriateness of the product.

Drug Interactions

No specific drug interactions have been identified for the product. 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 K19 Relief (menthol). 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 up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

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 associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when discussing treatment options in this context.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when considering this medication for lactating patients.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, close monitoring of the patient is essential to identify any adverse effects that may arise.

Management procedures should be initiated promptly, guided by the physician's recommendations. This may include supportive care and symptomatic treatment as necessary. It is crucial to follow established protocols for managing overdosage to ensure patient safety and optimal outcomes.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly after application, as this could interfere with the product's effectiveness and safety.

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 aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients on the following important points: the product is for external use only; contact with eyes and mucous membranes should be avoided; if symptoms persist for more than 7 days, patients should discontinue use and consult a physician; the medication should be kept out of reach of children, and if swallowed, a physician should be consulted. Additionally, it should not be applied to wounds or damaged skin, should not be bandaged tightly, and pregnant or breastfeeding patients should contact a physician before use.

Drug Information (PDF)

This file contains official product information for K19 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)