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MGC Health

MGC-YNBY Assorted Citrus Drops 30 2023

Approved
Approval ID

3de66240-441c-00ad-e063-6294a90a4a05

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

DUNS: 411759931

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cough Drops Assorted Citrus Vitamin C

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83698-126
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Cough Drops Assorted Citrus Vitamin C
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (11)

LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BETA CAROTENEInactive
Code: 01YAE03M7J
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
MENTHOLActive
Quantity: 2.7 mg in 1 1
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2022

Package Label - Principal Display Panel

MGC label 30CT30 CT, NDC 83173-126-30

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/28/2020

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/28/2020

Purpose

Purposes cough suppressant, oral anesthetic

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/28/2020

Active Ingredient(s)

Menthol 2.7

WARNINGS SECTION

LOINC: 34071-1Updated: 3/28/2020

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 1/1/2023

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 3/28/2020

Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 3/28/2020

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/28/2020

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/28/2020

Other information

■ 10 calories per drop ■ contains: SOY.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/28/2020

Inactive ingredients

MENTHOL
BETA CAROTENE
CITRIC ACID
ASCORBIC ACID
ACESULFAME POTASSIUM
GLUCOSE SYRUP
FD&C RED NO. 40
SOY LECITHIN
SUCROSE
SODIUM ASCORBATE
WATER

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/1/2023

Call 2396311907 or visit our website: www.mgc.us

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MGC Health - FDA Drug Approval Details