FDA.reportPublic FDA data

Leader Throat Soothing Drops Creamy Strawberry

Manufacturer
Cardinal Health 110, LLC. DBA Leader | Medical Group Care LLC | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:27:42

Label at a glance#

ProductLeader Throat Soothing Drops Creamy Strawberry
Active ingredientPECTIN
Label structure10 sections

Indications and uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Dosage and administration

• adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. • children under 5 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 (per drop)

OTC - ACTIVE INGREDIENT SECTION

Pectin 7 mg

Purposes

OTC - PURPOSE SECTION

oral demulcent

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor discomfort and protection of irritated areas in 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.

If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

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 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. • children under 5 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, citric acid, corn syrup, FD&C blue 2, FD&C red 40, lactic acid, malic acid, potassium citrate, soy lecithin, strawberry flavor, sucrose, sucralose, titanium dioxide, water.

Questions?

OTC - QUESTIONS SECTION

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
700897pectin 7 MG Oral LozengePSN2
700897pectin 7 MG Oral LozengeSCD2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0711-1Leader Throat Soothing Drops Creamy Strawberry30 in 1 BAGLOZENGE302

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-071170000-0711-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA CAROTENE01YAE03M7JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
CORN SYRUP9G5L16BK6NIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
MALIC ACID817L1N4CKPIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
PECTIN89NA02M4RXACTIB

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 Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
ndc (package): 70000-0711-1
ndc (product): 70000-0711
ndc11 (package): 70000071101
spl id: 468b64f1-1d8f-9d26-e063-6294a90a2d64
spl set id: 26cd146a-6461-604f-e063-6394a90ac36e

Reported adverse events (FAERS/openFDA)#

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