Active Ingredient

Manufacturer
Mondelez Global LLC | Mondelez Canada Inc.
Effective date
2026-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:01

Label at a glance#

ProductHalls Sugar Free Mountain Menthol
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 5.8 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 warnings: 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

.

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

  • phenylketonurics: contains phenylalanine 2 mg per drop
  • excessive consumption may have a laxative effect
  • 5 calories per drop
  • contains: SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<acesulfame potassium, aspartame, eucalyptus oil, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Questions?

OTC - QUESTIONS SECTION

<Call 1-800-524-2854, Monday to Friday2, 9 AM - 6 PM Eastern Time or visit our website atwww.gethalls.com>

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SF Mountain Menthol.jpgSF Mountain Menthol.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
896994Halls 5.8 MG Oral LozengePSN1
476973menthol 5.8 MG Oral LozengePSN1
896994menthol 5.8 MG Oral Lozenge [Halls]SBD1
476973menthol 5.8 MG Oral LozengeSCD1
896994Halls 5.8 MG Oral LozengeSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12546-724-01HallsSugar Free Mountain Menthol150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLOZENGE1500001
12546-724-70HallsSugar Free Mountain Menthol70 in 1 BAGLOZENGE701
12546-724-98HallsSugar Free Mountain Menthol225 in 1 JARLOZENGE2251

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
12546-72412546-724-01, 12546-724-70, 12546-724-98

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 Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
ndc (package): 12546-724-01
ndc (package): 12546-724-98
ndc (package): 12546-724-70
ndc (product): 12546-724
ndc11 (package): 12546072470
ndc11 (package): 12546072498
ndc11 (package): 12546072401
spl id: 509f233e-ff02-8927-e063-6394a90a9929
spl set id: 509f233e-ff01-8927-e063-6394a90a9929

Reported adverse events (FAERS/openFDA)#

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