FDA.reportPublic FDA data

Leader Cough Drops Vanilla Honey

Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | Medical Group Care LLC
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:28:36

Label at a glance#

ProductLeader Cough Drops Vanilla Honey
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

temporarily relieves: • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Dosage and administration

• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor • children under 2 years of age: ask a doctor

Storage and handling

• store at room temperature. • keep away from excessive heat or sunlight • do not use if primary bag seal has been torn or broken. • contains: SOY

Label contents#

Full prescribing information#

Active ingredient (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant/oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:
• cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)

When using this productdo not exceed recommended dosage

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. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
• children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at room temperature.
• keep away from excessive heat or sunlight
• do not use if primary bag seal has been torn or broken.
• contains: SOY

Inactive ingredients

INACTIVE INGREDIENT SECTION

beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.

Questions or comments?

OTC - QUESTIONS SECTION

Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM -5 PM Eastern Time 

SPL UNCLASSIFIED SECTION

RESEALABLE BAG

Gluten and Dairy-Free

Soothing Drops

COMPARE TO HALLS® active ingredient*

CLOSE BAG TO MAINTAIN FRESHNESS

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com   1-800-200-6313
Essential to Care™ Since 1979

Made in China

©2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

*This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®.

Contains 10 calories per lozenge

CHOKING WARNING: SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4. CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

All LEADER™ Brand Products Have A 100% Money Back Guarantee
Return to place of purchase if not satisfied.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vanilla HoneyVanilla Honey

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616344menthol 2.5 MG Oral LozengePSN2
616344menthol 2.5 MG Oral LozengeSCD2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83698-692-30Leader Cough Drops Vanilla Honey30 in 1 BAGLOZENGE302

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83698-69283698-692-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA CAROTENE01YAE03M7JIACT
CORN SYRUP9G5L16BK6NIACT
HONEYY9H1V576FHIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
Leader Cough Drops Vanilla HoneyMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a93c2c-a663-e3d1-e063-6394a90ad8592025-12-26WarningsExact identifier
ndc (package): 83698-692-30
ndc (product): 83698-692
ndc11 (package): 83698069230
spl id: 46dc2cc8-28b3-32cb-e063-6394a90a802c
spl set id: 26a93c2c-a663-e3d1-e063-6394a90ad859

Reported adverse events (FAERS/openFDA)#

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