Halls

Manufacturer
Mondelēz Group LLC | Mondelēz Canada Inc.
Effective date
2016-08-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:24:43

Label at a glance#

ProductHalls Menthol
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 18 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

<citric acid, eucalyptus oil, FDC blue 1, flavors, glucose syrup, potassium citrate, soy lecithin, 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 12546-314-09 Halls Extra Strong Menthol Flavor 9ct Stick>MM1MM1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130000000000000GTIN-13: 0000000000000
EAN-13: 0000000000000
GTIN-12: 000000000000
UPC-A: 000000000000
GTIN storage (14 digits): 00000000000000
DL_Halls Extra Strong_9ct.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

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
12546-32112546-321-09

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 185 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate

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
e2b4dbf1-0da0-3045-e053-2a95a90a7bcefa56c07b-209f-45a4-a31b-7bec293bcc8d2022-06-30WarningsExact identifier
spl set id: fa56c07b-209f-45a4-a31b-7bec293bcc8d

Reported adverse events (FAERS/openFDA)#

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