Medactive Oral Relief

Description

MedActive® Oral Relief Spray is formulated to provide relief from oral discomfort. This oral demulcent features a new Vanillamint flavor and contains ULTRAMULSION® and Spilanthes extract. The product is composed of 6% glycerin, which contributes to its soothing properties. Each bottle contains 1 fluid ounce (29.5 mL) of the spray, and it is identified by the National Drug Code (NDC) 49741-101901.

Uses and Indications

This drug is indicated for the temporary relief of minor discomfort and for the protection of irritated areas in the sore mouth and sore throat.

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

Dosage and Administration

The product may be used as needed or as directed by a dentist or doctor. For adults and children aged 2 years and older, the bottle should be held upright. The user should gently press down on the spray mechanism to apply the product directly to the affected areas in the mouth, approximately 3 to 4 times per application. It is important not to rinse out the mouth after application.

Children under 12 years of age should be supervised during the use of this product to ensure proper administration. For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

The route of administration is oral, with the product being applied directly to the affected areas in the mouth using a spray method. The frequency of application is approximately 3 to 4 times per session, as needed or as directed by a healthcare professional.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients should be advised to seek immediate medical attention if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied by fever, headache, rash, nausea, or vomiting. In such cases, prompt consultation with a healthcare professional is essential. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, patients are encouraged to contact their dentist or physician for further evaluation.

In the event of accidental ingestion of an excessive amount of the spray, it is critical to obtain medical assistance or contact a Poison Control Center without delay. Healthcare professionals should emphasize the importance of avoiding contact with the eyes to prevent potential irritation or injury.

Monitoring for these symptoms and ensuring timely intervention can significantly enhance patient safety and treatment outcomes.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Serious adverse reactions include a warning regarding sore throat. If patients experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, they are advised to consult a doctor promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients should seek evaluation from a dentist or doctor.

In the event of accidental ingestion of an excessive amount of the spray, it is crucial for patients to seek medical help or contact a Poison Control Center immediately. Furthermore, patients should be cautioned to avoid contact with the eyes to prevent potential complications.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Medactive Oral Relief (spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be supervised during the use of this product to ensure safe application. For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use.

For children aged 2 years and older, the product should be applied by holding the bottle upright. The caregiver should gently press down on the spray and apply it directly to the affected areas in the mouth, approximately 3-4 times per application. It is important not to rinse out the product after application.

Geriatric Use

There is no specific information available 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

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdosage, particularly if an excessive amount of the spray is accidentally ingested, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Prompt intervention is crucial to manage potential adverse effects associated with overdosage. Symptoms may vary depending on the specific circumstances of the incident; therefore, a thorough assessment by medical personnel is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to address any complications that may arise from the overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)