FDA.reportPublic FDA data

Sore Throat Logenzes

Manufacturer
REMEDYREPACK INC.
Effective date
2022-07-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:57:03

Label at a glance#

ProductSore Throat Logenzes Sore Throat
Active ingredientBENZOCAINE, MENTHOL
Label structure10 sections

Indications and uses

temporary relief of occasional sore throat sore mouth minor mouth irritation pain associated with canker sores

Dosage and administration

adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: ask a doctor

Storage and handling

tamper evident packaging: Do not use if outer box or blister is open or damaged.  store at room temperature protect contents from moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)Purpose
 Benzocaine 15 mg Oral pain reliever
 Menthol 3.6 mg Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

  • Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning

SPL UNCLASSIFIED SECTION

  • If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use in a child under 5 years of age.

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
  • children under 5 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • tamper evident packaging: Do not use if outer box or blister is open or damaged. 
  • store at room temperature
  • protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-616-2471

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Sore Throat LogenzesSore Throat Sore Throat

GENERIC: Benzocaine and Menthol

DOSAGE: LOZENGE

ADMINSTRATION: ORAL

NDC: 70518-3262-0

COLOR: red

FLAVOR: CHERRY

SHAPE: ROUND

SCORE: No score

SIZE: 18 mm

PACKAGING: 18 in 1 BLISTER PACK

OUTER PACKAGING: 18 in 1 CARTON

ACTIVE INGREDIENT(S):

  • MENTHOL 3.6mg in 1
  • BENZOCAINE 15mg in 1

INACTIVE INGREDIENT(S):

  • FD&C RED NO. 40
  • PROPYLENE GLYCOL
  • WATER
  • CORN SYRUP
  • ALLYL SUCROSE
  • HYDROGENATED SOYBEAN OIL

MM1MM1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6255-49EA - Each0904-6255a2eb59a3-971e-4b7e-9167-67437d05552812013-07-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-326270518-3262-0
0904-6255

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CORN SYRUP9G5L16BK6NIACT
ALLYL SUCROSEVI3D59RW0UIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
ndc (product): 0904-6255
07d7e496-5bdc-99d1-e063-6294a90a9db55115bd75-96ca-4888-b06d-94bcd885a90e2023-10-16WarningsExact identifier
spl set id: 5115bd75-96ca-4888-b06d-94bcd885a90e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.