ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE- menthol lozenge

ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE by

Drug Labeling and Warnings

ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE by is a Otc medication manufactured, distributed, or labeled by Valda USA Labeler, Disch AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Cough suppressant, oral anesthetic

Active Ingredient (in each drop)

Menthol, 3.6 mg

Uses

Temporarily relieves:

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

Warnings

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

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

Stop use and ask a doctor if

• 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

Keep out of reach of children.

Directions

• 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

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

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORIGINAL MENTHOL AND EUCALYPTUS SUGAR FREE 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84686-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.6 mg

Inactive Ingredients
Ingredient Name	Strength
CURCUMIN (UNII: IT942ZTH98)
EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA (UNII: 5C5403N26O)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CORN OIL (UNII: 8470G57WFM)
BEESWAX (UNII: 2ZA36H0S2V)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	green (FD&C BLUE NO.1)	Score	no score
Shape	BULLET	Size	13mm
Flavor	MENTHOL (MENTHOL & EUCALYPTUS)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84686-101-50	50 in 1 PACKAGE; Type 0: Not a Combination Product	12/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/02/2024

Labeler - Valda USA Labeler (119306540)

Establishment
Name	Address	ID/FEI	Business Operations
Disch AG		480002609	manufacture(84686-101)