Halls

Manufacturer
Mondelez Global LLC | MSI Express Inc | Mondelez Canada Inc
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:47:38

Label at a glance#

ProductHalls Sugar Free Mentho-Lyptus
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

adults and children 5 years and over: dissolve 2 drops (one at a time) 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 2.7 mg>

Purposes

OTC - PURPOSE SECTION

<Cough Suppressant, Oral Anesthetic>

Uses

INDICATIONS & USAGE SECTION

<temporarily relieves:

  • cough due to a cold
  • occasional minor irritation or sore throat>

Warnings

WARNINGS SECTION

<Sore throat warning: if sore throat is severe, persist 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.>

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 5 years and over: dissolve 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • phenylketonurics: contains phenylalanine 0.5 mg per drop
  • excessive consumption may have a laxative effect
  • <5 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, isomalt, soy lecithin, 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

Halls minis sugar free mentho-lyptus 24ct frontHalls minis sugar free mentho-lyptus 24ct frontHalls Minis sugar free mentho-lyptus 24ct backHalls Minis sugar free mentho-lyptus 24ct back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1250183Halls 2.7 MG Oral LozengePSN13
433196menthol 2.7 MG Oral LozengePSN13
1250183menthol 2.7 MG Oral Lozenge [Halls]SBD13
433196menthol 2.7 MG Oral LozengeSCD13
1250183Halls 2.7 MG Oral LozengeSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-349-03HallsSugar Free Mentho-Lyptus11667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE1166713
12546-349-24HallsSugar Free Mentho-Lyptus24 in 1 PACKAGELOZENGE2413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-349HALLS SUGAR FREE MENTHO-LYPTUS (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]13Current NDC, Legacy NDC, 2 package rows20241222_96046858-c57b-426e-8279-91b35e05bcdb.zip

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
12546-34912546-349-03, 12546-349-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
ndc (package): 12546-349-03
ndc (package): 12546-349-24
ndc (product): 12546-349
ndc11 (package): 12546034924
ndc11 (package): 12546034903
spl id: 29b505f3-6cfa-cf62-e063-6394a90a812f
spl set id: 96046858-c57b-426e-8279-91b35e05bcdb

Reported adverse events (FAERS/openFDA)#

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