CankerMelts BENZOCAINE QUEST PRODUCTS, LLC FDA Approved Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores
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Substance Benzocaine
Route
ORAL
Applications
M022
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each self-adhering tablet) Benzocaine 15mg
Inactive Ingredients
Inactive Ingredients Acacia gum cellulose gum hyaluronic acid magnesium stearate maize dextrin methylcobalamin (vitamin B12) mint oil sodium bicarbonate xylitol
Strengths
15 mg
Treats Conditions
Uses For Temporary Relief Of Pain Associated With Canker Sores Minor Irritation Mouth Sores
Pill Appearance
Shape: round Color: white Imprint: CM

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
U3RSY48JW5
Packaging

CankerMelts® 15mg carton of 20 PDP

Package Descriptions
  • CankerMelts® 15mg carton of 20 PDP

Overview

Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores

Indications & Usage

Uses for temporary relief of pain associated with: canker sores minor irritation mouth sores

Dosage & Administration

Directions Adults and children age 5 and older: Affix one tablet as directed below and allow to slowly dissolve in the mouth. May be repeated every 2 hours as needed or directed by a doctor or dentist. This product may last over 2 hours. Placement: CankerMelts are bi-layered tablets with a dimple on the adhesive side and a pain reliever on the domed side marked CM. Place the adhesive side with a dimple against teeth or gums or braces or appliance. Place opposite or adjacent to the sore. Hold tablet in place with your cheek or tongue for 10 seconds to initiate adhesion. Adhesion will strengthen over the next few minutes. It may be removed at any time. Children under 5 years of age: Do not use.

Warnings & Precautions
Warnings Methemoglobinemea warning: Use of this product may cause methemoglobinemea, a serious- condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. Do not use: this product for more than 7 days unless directed by a doctor or dentist in children under 5 years of age When using this product do not exceed recommended dosage. Stop use and ask a doctor or dentist if: if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children in case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Oral Pain Relief

Do Not Use

Do not use: this product for more than 7 days unless directed by a doctor or dentist in children under 5 years of age

When Using

When using this product do not exceed recommended dosage.

Stop Use & Ask a Doctor

Stop use and ask a doctor or dentist if: if sore mouth symptoms do not improve in 7 days if irritation, pain, or redness persists or worsens if swelling, rash or fever develops

Keep Out of Reach of Children

Keep out of reach of children in case of overdose, get medical help or contact a Poison Control Center right away.


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