Mixed Berry Sore Throat Lozenges BENZOCAINE TOPCO ASSOCIATES FDA Approved Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold
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Substance Benzocaine
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each lozenge) Benzocaine 7.5 mg Dextromethorphan hydrobromide 5 mg
Inactive Ingredients
Inactive ingredients: Acesulfame potassium corn starch corn syrup FD&C blue no. 1 FD&C red no. 40 glycerin medium chain triglycerides natural and artificial flavors propylene glycol soybean oil sucrose and water.
Strengths
7.5 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Occasional Minor Mouth Irritation Sore Mouth And Sore Throat Cough Due To Minor Throat And Bronichial Irritation As May Occur With The Common Cold
Pill Appearance
Shape: round Color: red Imprint: B

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0036800418400
UNII
U3RSY48JW5 9D2RTI9KYH
Packaging

TopCare Mixed Berry Benx-Dex 18ct

Package Descriptions
  • TopCare Mixed Berry Benx-Dex 18ct

Overview

Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold

Indications & Usage

Uses temporarily relieves these symptoms: occasional minor mouth irritation, sore mouth and sore throat cough due to minor throat and bronichial irritation as may occur with the common cold

Dosage & Administration

Directions adults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctor children 6 to 12 years - take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor children under 6 years of age - do not use

Warnings & Precautions
Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens, see your dentist or doctor promptly. 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.
Purpose

Purposes Oral Pain Reliever Cough Suppressant

Do Not Use

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. for teething in children under 2 years of age

Stop Use & Ask a Doctor

Stop use and ask doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.

Questions

Questions? Or to report an adverse event call 1-888-423-0139


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