Halls

Manufacturer
Mondelēz Global LLC | Mondelēz Canada Inc.
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:20

Label at a glance#

ProductHalls Mentholyptus
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

Temporarily relieves: cough due to a cold occasional minor irritation or sore throat

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 6.4 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, 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.>

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

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

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

Questions

OTC - QUESTIONS SECTION

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

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ML 9ct stickML 9ct stick

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1857615Halls 6.4 MG Oral LozengePSN3
1857613menthol 6.4 MG Oral LozengePSN3
1857615menthol 6.4 MG Oral Lozenge [Halls]SBD3
1857613menthol 6.4 MG Oral LozengeSCD3
1857615Halls 6.4 MG Oral LozengeSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-334-09HallsMentholyptus9 in 1 PACKAGELOZENGE93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-334HALLS MENTHOLYPTUS (MENTHOL) LOZENGE [MONDELĒZ GLOBAL LLC]3Current NDC, Legacy NDC, 1 package rows20240627_f5292c5b-5608-4e13-afc2-4f3d7133da88.zip

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
12546-33412546-334-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
ndc (package): 12546-334-09
ndc (product): 12546-334
ndc11 (package): 12546033409
spl id: 1bc29960-5e7b-e8ab-e063-6294a90a3f80
spl set id: f5292c5b-5608-4e13-afc2-4f3d7133da88

Reported adverse events (FAERS/openFDA)#

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