ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE

Manufacturer
Valda USA Labeler | Disch AG
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:45

Label at a glance#

ProductORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporarily relieves: Minor sore throat Cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants

Dosage and administration

Adults and children 5 years and over:  Dissolve 2 drops (one at a time) slowly in mouth.  Repeat every 2 hours as needed. Children under 5 years of age: Ask a doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Purpose

Cough suppressant, oral anesthetic

Active Ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Menthol, 3.6 mg

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

  • Minor sore throat
  • Cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants

Warnings

WARNINGS SECTION

Sore throat warning: If sore throat is severe and persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These symptoms may be serious.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • Cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • Sore mouth does not improve in 2 days
  • Irritation, pain, or redness persists or worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 5 years and over:  Dissolve 2 drops (one at a time) slowly in mouth.  Repeat every 2 hours as needed.
  • Children under 5 years of age: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Curcumin, eucalyptus globulus, FD&C Blue No. 1, glycerin, gum arabic, purified water, sorbitol, vegetable oil, white beeswax, xylitol

Questions?

OTC - QUESTIONS SECTION

Or to report adverse events call 1-877-349-9443

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VP-16118-50-0.jpgVP-16118-50-0.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84686-101-50ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE50 in 1 PACKAGELOZENGE501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84686-101ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE (MENTHOL) LOZENGE [VALDA USA LABELER]11 package rows20250129_6994aebf-5f8f-4ea9-ad04-766a2f2bab58.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84686-10184686-101-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bcbade43-5355-459b-a5a1-9302f6053ba26994aebf-5f8f-4ea9-ad04-766a2f2bab582026-05-19WarningsExact identifier
spl set id: 6994aebf-5f8f-4ea9-ad04-766a2f2bab58

Reported adverse events (FAERS/openFDA)#

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