Oral Pain Relief

Description

Discount Drug Mart Oral Pain Relief is a pharmaceutical product designed for the alleviation of oral pain. It is formulated to provide effective relief from discomfort associated with various oral conditions. The product is available in a dosage form suitable for oral administration. Specific details regarding its active ingredients, molecular weight, and chemical composition are not provided in the extracted facts. The formulation is intended for use in a clinical setting, ensuring that it meets the necessary standards for safety and efficacy in pain management.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches, canker sores, minor injuries of the mouth and gums, and minor irritation of the mouth and gums caused by dentures.

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

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the cavity and around the gums surrounding the teeth. This application may be performed up to four times daily or as directed by a dentist or doctor.

Children under 12 years of age should be supervised during the use of this product to ensure safe and effective application.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use to determine the appropriateness of the product for this age group.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage for more than 7 days without the guidance of a dentist or doctor. Prolonged use beyond this duration may lead to potential complications or adverse effects.

Warnings and Precautions

Patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. The potential for severe allergic reactions necessitates careful screening for such allergies prior to administration.

This product is flammable; therefore, it is imperative to keep it away from fire or flame. Healthcare professionals should advise patients to avoid smoking during application and until the product has completely dried to minimize the risk of ignition.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: swelling, rash, or fever develops; irritation, pain, or redness persists or worsens; or if symptoms do not show improvement within 7 days. These signs may indicate an adverse reaction that requires further evaluation.

In the event of an overdose or suspected allergic reaction, immediate medical assistance should be sought. Patients or caregivers should be advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning includes an allergy alert; individuals with a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

In clinical use, patients are advised to discontinue use and consult a healthcare professional if they experience any of the following: swelling, rash, or fever; persistent or worsening irritation, pain, or redness; or if symptoms do not improve within 7 days.

In the event of an overdose or an allergic reaction, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center. These precautions are essential to ensure patient safety and effective management of any adverse reactions.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

No specific interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory tests is not indicated in relation to this product.

Packaging & NDC

Below are the non-prescription pack sizes of Oral Pain Relief (oral pain reliever). 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 safety and proper administration. For infants and children under 2 years of age, it is advised to consult a dentist or doctor prior to use to assess appropriateness and safety.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of Oral Pain Relief (Benzocaine 20%) in pregnant patients mentioned in the prescribing information. The insert does not indicate whether the product is contraindicated during pregnancy or if there are any known risks to the fetus.

Healthcare professionals should consider the lack of data on the safety of benzocaine use in pregnant women when advising patients. As with any medication, the potential benefits must be weighed against any unknown risks. It is advisable for women of childbearing potential to consult with their healthcare provider before using this product during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose or an allergic reaction, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely treatment and improve patient outcomes.

Management of an overdose should be guided by the severity of symptoms and the specific agent involved. Healthcare providers should follow established protocols for overdose management, which may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary.

It is crucial for healthcare professionals to remain vigilant and proactive in addressing potential overdose situations to mitigate risks and ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. In the event of an overdose or an allergic reaction, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to exceed the recommended dosage or to use the medication for more than 7 days unless directed by a dentist or doctor. It is important for patients to understand the significance of adhering to this guideline to avoid potential complications.

Additionally, healthcare providers should counsel patients to discontinue use and consult a doctor if they experience any of the following: swelling, rash, or fever; persistent or worsening irritation, pain, or redness; or if symptoms do not improve within 7 days. This information is crucial for ensuring patient safety and effective treatment outcomes.

Storage and Handling

This preparation is supplied in a tube format, specifically designed for temporary relief of toothache until professional dental care can be obtained. It is crucial to ensure that the tube tip remains intact prior to opening; the product should not be used if the tube tip is cut before use.

For optimal storage, the product should be kept at room temperature, away from direct sunlight and moisture. It is important to handle the tube with care to maintain its integrity and effectiveness. Continuous use of this preparation is not recommended, as it is intended solely for temporary relief.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)