FDA.reportPublic FDA data

MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops

Manufacturer
Medical Group Care LLC
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:39

Label at a glance#

ProductMENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

temporarily relieves: • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

Dosage and administration

• 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

• 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 (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.4 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant/oral anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:
• cough due to a cold • occasional minor irritation, pain, 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.

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

When using this product do not exceed recommended dosage

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. A persistent cough may be a sign of a serious condition
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens

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 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

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

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

Questions or comments?

OTC - QUESTIONS SECTION

Call +1-866-306-9136
You may also report concerns to this phone number
Monday to Friday, 9 AM -5 PM Eastern Time or visit our website at www.mgc.us

SPL UNCLASSIFIED SECTION

RESEALABLE BAG

COMPARE TO ACTIVE INGREDIENT OF HALLS®

MENTHOL FLAVOR

√ SOOTHING DROPS
√ GLUTEN FREE
√ DAIRY FREE

CLOSE BAG TO MAINTAIN FRESHNESS

DISTRIBUTED BY: 
MEDICAL GROUP CARE, LLC
NAPLES, FL 34110

MADE IN CHINA

This product is not manufactured or distributed by
Intercontinental Great Brands LLC., owner of the registered trademark HALLS®

Contains 12 calories per lozenge
customerservice@mgc.us

CHOKING HAZARD:
• SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4.
• CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough DropsCough Drops

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83173-110MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC COUGH DROPS (MENTHOL) LOZENGE [MEDICAL GROUP CARE LLC]1Unmatched20240704_00b2cbfe-c60e-4e2d-b4f3-ff8b91d33239.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83173-11083173-110-30, 83173-110-80

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

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
3b405e85-a647-e100-e063-6394a90a65bc00b2cbfe-c60e-4e2d-b4f3-ff8b91d332392025-07-31WarningsExact identifier
spl set id: 00b2cbfe-c60e-4e2d-b4f3-ff8b91d33239

Reported adverse events (FAERS/openFDA)#

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