Makesense

Description

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

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times per day. For children under 12 years of age, it is advised to consult a physician prior to use.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. It should not be used in conjunction with a heating pad, as this may increase the risk of burns or skin damage. Additionally, the product is contraindicated for children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

While using this product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, do not apply tight bandages, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens or symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; if excessive skin irritation occurs; or if there is noticeable redness over the affected area.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought. It is also recommended that patients consult a doctor prior to use if there is any redness over the affected area.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Makesense (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

For adolescents and children aged 12 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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, given the lack of targeted data.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients 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 on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that the product is not recommended for use in children under 12 years of age who have arthritis-like conditions. They should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days.

Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience excessive skin irritation or notice redness over the affected area. It is crucial to remind patients to avoid contact with eyes or mucous membranes while using the product and to refrain from tightly bandaging the area of application.

Lastly, patients should be encouraged to consult a doctor before using the product if they have redness over the affected area.

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, maintaining a range of 20 to 25°C (68 to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)