Shelo Nabel Arnica Gel

Description

The drug is identified by the 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 several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

No specific dosage or administration information is provided in the text. Therefore, healthcare professionals are advised to refer to the relevant prescribing information or clinical guidelines for detailed instructions regarding dosage, administration routes, and techniques. It is essential to consider patient-specific factors and clinical judgment when determining the appropriate dosing regimen.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

The absence of specific warnings and precautions in the provided insert necessitates a careful approach to the safe use of the medication. Healthcare professionals are advised to remain vigilant and consider the following general principles when prescribing and monitoring treatment.

Healthcare providers should ensure that patients are adequately informed about the importance of adherence to prescribed dosages and the potential for adverse effects, even in the absence of explicitly stated warnings. Continuous patient education regarding the medication's use is essential to mitigate risks.

Monitoring parameters should be established based on the individual patient's health status and any concurrent medications. Regular assessments may be warranted to evaluate the patient's response to treatment and to identify any emerging issues promptly.

In the event of any unexpected symptoms or reactions, healthcare professionals should encourage patients to seek immediate medical attention. It is crucial to maintain open lines of communication, allowing patients to report any concerns or side effects they may experience during the course of treatment.

Overall, while specific warnings and precautions are not detailed in the insert, a proactive and vigilant approach to patient management is essential to ensure safety and efficacy in the use of this medication.

Side Effects

There are no specific side effects or adverse reactions listed in the provided text. Therefore, no adverse reactions can be detailed for patients, participants, or subjects based on the available information.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Shelo Nabel Arnica Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the absence of relevant data.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

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

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for SHELO NABEL ARNICA GEL. Therefore, the effects on breastfed infants and the excretion of the drug in human milk are not established. Healthcare professionals should exercise caution when recommending this product to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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 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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

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. Additionally, the product must be protected from light to prevent degradation. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)