Halls

Manufacturer
Mondelez Global LLC | MSI Express Inc | Mondelez Canada Inc
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:55:42

Label at a glance#

ProductHalls Sugar Free Honey Lemon
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 2.5 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

  • excessive consumption may have a laxative effect
  • <5 calories per drop
  • Contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<beta carotene, citric acid, eucalyptus oil, flavors, isomalt, soy lecithin, sucralose, 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 SF Mini Honey Lemon Pouch frontHalls SF Mini Honey Lemon Pouch frontHalls SF Mini Honey Lemon Pouch backHalls SF Mini Honey Lemon Pouch back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
896992Halls 2.5 MG Oral LozengePSN14
616344menthol 2.5 MG Oral LozengePSN14
896992menthol 2.5 MG Oral Lozenge [Halls]SBD14
616344menthol 2.5 MG Oral LozengeSCD14
896992Halls 2.5 MG Oral LozengeSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-347-03HallsSugar Free Honey Lemon11667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE1166714
12546-347-24HallsSugar Free Honey Lemon24 in 1 PACKAGELOZENGE2414
12546-347-48HallsSugar Free Honey Lemon2 in 1 BAGLOZENGE214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-347HALLS SUGAR FREE HONEY LEMON (MENTHOL) LOZENGE [MONDELEZ GLOBAL LLC]14Current NDC, Legacy NDC, 3 package rows20250223_5d56ccd2-1c28-4750-9454-44809091ad2f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-34712546-347-03, 12546-347-24, 12546-347-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
ndc (package): 12546-347-24
ndc (package): 12546-347-03
ndc (package): 12546-347-48
ndc (product): 12546-347
ndc11 (package): 12546034703
ndc11 (package): 12546034724
ndc11 (package): 12546034748
spl id: 2d67d823-08cc-57cc-e063-6394a90a1ce5
spl set id: 5d56ccd2-1c28-4750-9454-44809091ad2f

Reported adverse events (FAERS/openFDA)#

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