MedPath

MGC Health Cough Drops

Original Herb Flavor Menthol Cough Drop MGC-Xiamen

Approved
Approval ID

779ddb89-b6e2-4bfb-bcb5-8c7ec916675a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 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.

MENTHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83698-131
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (15)

CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SAMBUCUS NIGRA FLOWERInactive
Code: 07V4DX094T
Classification: IACT
HOREHOUNDInactive
Code: K08036XEJV
Classification: IACT
HYSSOPUS OFFICINALIS FLOWERING TOPInactive
Code: X7HKN4FOJI
Classification: IACT
LEMON BALM OILInactive
Code: MJ76269K9S
Classification: IACT
TILIA CORDATA FLOWERInactive
Code: CFN6G1F6YK
Classification: IACT
MALVA SYLVESTRIS LEAFInactive
Code: 17H39B00T5
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
SAGEInactive
Code: 065C5D077J
Classification: IACT
THYMEInactive
Code: CW657OBU4N
Classification: IACT
WILD THYMEInactive
Code: KXK6I80R8W
Classification: IACT
MENTHOLActive
Quantity: 4.8 mg in 1 1
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

temporarily relieves:

  • cough due to a cold
  • occasional minor irritation and pain due to sore throat or sore mouth

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Drug Facts

Purpose

Cough suppressant, Oral anesthetic

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active Ingredient (in each drop)

Menthol, 4.8 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/12/2025

Ask doctor before use if you have

  • persistent chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/12/2025

When using this productdo not exceed recommended dosage

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

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. These could be signs of a serious 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: 8/12/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • 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 SECTION

LOINC: 44425-7Updated: 8/12/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive Ingredients

caramel, corn syrup, flavors, herbal extract
blend (elderflower extract, horehound extract, hyssop extract, lemon
balm extract, linden flower extract, malva sylvestris (mallow) leaf extract,
peppermint extract, sage extract, thyme extract, wild thyme extract),
soy lecithin, sucrose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

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

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