NICE Menthol Cough Drops

Manufacturer: Leosons Overseas Corp
Effective date: 2024-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:38:06

Label at a glance#

ProductNICE Menthol Cough Drops

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

temporarily suppresses / relieves: coughs due to minor throat and bronchial irritation from a cold or inhaled irritants occasional minor sore throat pain

Dosage and administration

dissolve a lozenge slowly in mouth may be repeated every hour for coughs as needed or as directed by a doctor may be repeated every 2 hours for sore throat do not take more than 10 lozenges per day adults and children 6 years and older 5 mg children under 6 years ask a doctor

Contacts and useful links#

PhoneLabel contact1-855-452-9500

Label contents#

Full prescribing information#

Active ingredient & Purposes

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each lozenge)

Menthol 5 mg

OTC - PURPOSE SECTION

Active ingredient (in each lozenge)	Purposes
Menthol 5 mg.....	Cough Suppressant / Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily suppresses / relieves:

coughs due to minor throat and bronchial irritation from a cold or inhaled irritants
occasional minor sore throat pain

Warnings

WARNINGS SECTION

Warnings

Ask a doctor before use is you have

chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

Ask a doctor before use is you have

OTC - ASK DOCTOR SECTION

chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, swelling, nausea or vomiting
sore mouth symptoms lasts more than 7 days, or irritation, pain or redness continues or worsens

When using this product

OTC - WHEN USING SECTION

do not use more than directed, taking more may have a laxative effect

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

dissolve a lozenge slowly in mouth
may be repeated every hour for coughs as needed or as directed by a doctor
may be repeated every 2 hours for sore throat
do not take more than 10 lozenges per day

adults and children 6 years and older	5 mg
children under 6 years	ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame Potassium, Citric Acid, Eucalyptus Oil, Isomalt, Other Natural and Artificial Flavors.

Questions?

OTC - QUESTIONS SECTION

Call 1-855-452-9500 or email at info@leosonsintl.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nice Menthol 24ct Cough Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311508	menthol 5 MG Oral Lozenge	PSN	4
802773	N'ICE 5 MG Oral Lozenge	PSN	4
802773	menthol 5 MG Oral Lozenge [N'ICE]	SBD	4
311508	menthol 5 MG Oral Lozenge	SCD	4
802773	N Ice 5 MG Oral Lozenge	SY	4
802773	N'Ice 5 MG Oral Lozenge	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69626-0043-4	NICE Menthol Cough Drops	24 in 1 BLISTER PACK	LOZENGE	24		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69626-0043	NICE MENTHOL COUGH DROPS (MENTHOL) LOZENGE [LEOSONS OVERSEAS CORP]	4	Current NDC, Legacy NDC, 1 package rows	20241121_96d77897-475c-482c-e053-2995a90a2da4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NICE Menthol Cough Drops
Menthol
ACESULFAME POTASSIUM
ACESULFAME
ANHYDROUS CITRIC ACID
ISOMALT
EUCALYPTUS OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69626-0043	69626-0043-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
MENTHOL	L7T10EIP3A	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ISOMALT	S870P55O2W	IACT
EUCALYPTUS OIL	2R04ONI662	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICE Menthol Cough Drops	MENTHOL	Leosons Overseas Corp	96d77897-475c-482c-e053-2995a90a2da4	2024-11-19	Warnings	Exact identifier ndc (package): 69626-0043-4 ndc (product): 69626-0043 ndc11 (package): 69626004304 spl id: 2747630c-6f5b-a0fc-e063-6394a90ae659 spl set id: 96d77897-475c-482c-e053-2995a90a2da4

Reported adverse events (FAERS/openFDA)#

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