FDA.reportPublic FDA data

HALLS

Manufacturer
Mondelez Global LLC | Mondelez Canada Inc.
Effective date
2021-05-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:45:29

Label at a glance#

ProductHALLS Extra Strong Menthol Menthol
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

-sore throat -sore mouth

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

<(per drop) Menthol 20 mg>

Purposes

OTC - PURPOSE SECTION

<Oral anesthetic>

Uses

INDICATIONS & USAGE SECTION

<temporarily relieves occasional minor irritation and pain associated with:>

-sore throat

-sore mouth

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. These may be serious.>

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other Information

SPL UNCLASSIFIED SECTION

  • 10 calories per drop
  • Contains: SOY.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

<NDC12546-341-30 Halls Extra Strong Menthol Flavor 30ct Bag> image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-34112546-341-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POTASSIUM CITRATEEE90ONI6FFIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
1b642fb5-4573-95be-e063-6394a90a91ab4e957066-028f-4e25-b832-3b3c6ef280ba2024-06-21WarningsExact identifier
spl set id: 4e957066-028f-4e25-b832-3b3c6ef280ba

Reported adverse events (FAERS/openFDA)#

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