LEADER THROAT SOOTHING DROPS CREAMY STRAWBERRY- throat soothing creamy strawberry lozenge

Leader Throat Soothing Drops Creamy Strawberry by

Drug Labeling and Warnings

Leader Throat Soothing Drops Creamy Strawberry by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader, Medical Group Care LLC, Xiamen Kang Zhongyuan Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient (per drop)

Pectin 7 mg

Purposes

oral demulcent

Uses

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

Warnings

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.

KEEP OUT OF REACH OF CHILDREN

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

Directions

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

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

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?

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

Packaging

INGREDIENTS AND APPEARANCE

LEADER THROAT SOOTHING DROPS CREAMY STRAWBERRY 
throat soothing creamy strawberry lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0711
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	7 mg

Inactive Ingredients
Ingredient Name	Strength
BETA CAROTENE (UNII: 01YAE03M7J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CORN SYRUP (UNII: 9G5L16BK6N)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
MALIC ACID (UNII: 817L1N4CKP)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white, red	Score	no score
Shape	OVAL	Size	21mm
Flavor	STRAWBERRY (Creamy Strawberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0711-1	30 in 1 BAG; Type 0: Not a Combination Product	11/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/08/2024

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Registrant - Medical Group Care LLC (085137089)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.		411759931	manufacture(70000-0711)