Menthol Pain Relief Gel-Tube

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of muscle soreness and minor joint pains affecting various anatomical sites, including the wrist, knees, ankles, back, neck, hips, shoulders, and elbows.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply a thin film of the medication over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

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

After application, it is essential to wash hands thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for adverse effects.

• Concurrent use with heating pads or devices is contraindicated, as it may lead to increased risk of burns or skin irritation.

• The product should not be used in conjunction with other ointments, creams, sprays, or liniments to avoid possible interactions or compounded effects.

• Individuals with known allergies to any ingredients in this product should refrain from use to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be used in conjunction with heating pads or devices, nor should it be combined with other ointments, creams, sprays, or liniments. Individuals with known allergies to any ingredients in this product should refrain from use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any skin reactions occur, including but not limited to redness, swelling, blistering, or other discomfort. Additionally, if symptoms persist beyond 7 days, patients should be instructed to stop using the product and consult their healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical trials and postmarketing experiences, skin reactions have been reported, including redness, swelling, blistering, and other forms of discomfort.

If any of these skin reactions occur, patients are advised to stop using the product immediately. Additionally, if symptoms persist for more than 7 days, it is recommended that patients consult a healthcare professional for further evaluation and guidance.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to apply a thin film over the affected areas no more than four times daily.

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 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 seek medical advice 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 on 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 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 adhere to 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, the following management procedures are recommended:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Additionally, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

During postmarketing experience, skin reactions including redness, swelling, blistering, and other forms of discomfort have been reported. Additionally, there have been instances of symptoms persisting for more than 7 days. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center if the product is accidentally swallowed. It is important to inform patients that the product should not be applied to wounds or damaged skin, and they should avoid using it in conjunction with heating pads or devices.

Patients should be cautioned against using this product alongside other ointments, creams, sprays, or liniments to prevent potential adverse interactions. Additionally, healthcare providers should ensure that patients are aware of the importance of not using the product if they have a known allergy to any of its ingredients.

Patients should be instructed to discontinue use if they experience any skin reactions, such as redness, swelling, blistering, or other discomfort. Furthermore, they should be advised to stop using the product if their symptoms persist for more than 7 days.

When using this product, patients must be reminded to follow the directions provided and to avoid contact with the eyes, mucous membranes, or rashes. It is also essential to inform patients not to apply a tight bandage over the area of application.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Additionally, the product must be discarded after opening to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 12 years and older, not exceeding four times daily. For children under 12 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)