FDA.reportPublic FDA data

Halls

Manufacturer
Mondelēz Group LLC | Mondelēz Canada Inc.
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 23:38:25

Label at a glance#

ProductHalls Frozen Cherry
Active ingredientMenthol
Label structure11 sections

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 Ingredient

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 - STOP USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Enter section text here

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

  • 15 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<eucalyptus oil, FDC blue 2, FDC red 40, flavors, glucose syrup, glycerin, high fructose corn syrup, soy lecithin, sucralose, sucrose, water>

Questions

OTC - QUESTIONS SECTION

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

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

<NDC 12546-343-20 Halls Frozen Cherry Flavor 20ct bag>

MM1MM1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-34312546-343-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
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
097d835a-5251-6137-e063-6294a90a34bf6aa93d7f-6d47-447b-8420-e707d306220c2023-11-06WarningsExact identifier
spl set id: 6aa93d7f-6d47-447b-8420-e707d306220c

Reported adverse events (FAERS/openFDA)#

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