Medactive Oral Relief

Description

MedActive® Oral Relief Spray is an oral demulcent formulated to provide relief from oral discomfort. This product is presented in a 1 FL.OZ. (29.5 mL) dosage form and features a new natural spring flavor. The active formulation includes ULTRAMULSION® technology and Spilanthes extract, with glycerin constituting 6% of the composition. The product is identified by NDC 49741-1016-1.

Uses and Indications

This drug is indicated for the temporary relief of minor discomfort and 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, with approximately 3-4 sprays per application. It is important not to rinse the mouth after application.

Children under 12 years of age should be supervised during the use of this product. 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 3-4 times per application.

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should be advised to seek medical attention if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied or followed by symptoms such as 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 should be encouraged to see their dentist or doctor without delay.

In the event of accidental ingestion of an excessive amount of the spray, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center or seek emergency medical help to ensure appropriate management of the situation. It is also crucial to avoid contact with the eyes to prevent irritation or injury.

Side Effects

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

Severe adverse reactions include a warning regarding sore throat. If patients experience a sore throat that is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they are advised to consult a doctor promptly. Additionally, if symptoms related to a sore mouth do not improve within 7 days, patients should seek medical attention 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 avoid contact with the eyes to prevent potential complications.

These warnings highlight the importance of monitoring symptoms and seeking timely medical advice to ensure patient safety.

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

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. 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 nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk. Therefore, healthcare professionals may consider the use of this product in lactating mothers without specific concerns related to breastfeeding.

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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an excessive amount of the spray is accidentally ingested, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring the patient for any symptoms that may arise is essential, although specific symptoms related to overdosage are not detailed in the available data.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the management of overdose cases, ensuring that the patient receives appropriate evaluation and treatment based on their clinical presentation.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure safety. Patients should be informed about the potential risks associated with improper access to the medication by 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. 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)