Cough Drops

Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Effective date
2023-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:11

Label at a glance#

ProductCough Drops
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.muchildren under 5 years:ask a doctor.

Storage and handling

1,10calories per drop 2,contains :soy

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.18%

Purpose

OTC - PURPOSE SECTION

cough suppressant,oral anesthetic

Use

INDICATIONS & USAGE SECTION

Cough due to cold

Occasional minor imtation or sore throat

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

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

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if:
1,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.

2, sore mouth does not improve in 7 days

3,irritation, pain, or redness persists or worsens.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please do not place this product in an area accessible to unconscious people.

In case of accidental ingestion, seek medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.muchildren under 5 years:ask a doctor.

Other information

STORAGE AND HANDLING SECTION

1,10calories per drop

2,contains :soy

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid,eucalyptus oil,FD&C blue 1,FD&C red 40, flavors, glucose syrup, potassium citrate,soy lecithin,sucralose,sucrose,water.

Questions

OTC - QUESTIONS SECTION

Call2396311907 or visit our website :www.mgc.us

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

010102020303

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83698-001-01Cough Drops25 in 1 BOTTLEGRANULE251
83698-001-02Cough Drops30 in 1 BOTTLEGRANULE301
83698-001-03Cough Drops70 in 1 BOTTLEGRANULE701
83698-001-04Cough Drops80 in 1 BOTTLEGRANULE801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83698-001COUGH DROPS (MENTHOL) GRANULE [XIAMEN KANG ZHONGYUAN BIOTECHNOLOGY CO., LTD.]14 package rows20230916_0548ead3-57e6-2861-e063-6294a90ad401.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83698-00183698-001-01, 83698-001-02, 83698-001-03, 83698-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
0548ead3-57e7-2861-e063-6294a90ad4010548ead3-57e6-2861-e063-6294a90ad4012023-09-13WarningsExact identifier
spl id: 0548ead3-57e7-2861-e063-6294a90ad401
spl set id: 0548ead3-57e6-2861-e063-6294a90ad401

Reported adverse events (FAERS/openFDA)#

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