FDA.reportPublic FDA data

Halls

Manufacturer
Mondelez Global LLC | Mondelez Canada Inc.
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:21:56

Label at a glance#

ProductHalls Tropical Fruit
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

cough due to a cold occasional minor irritation or sore throat

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

Enter section text here

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

  • 10 calories per drop
  • Contains:  SOY.

Inactive ingredients

INACTIVE INGREDIENT SECTION

<beta carotene, eucalyptus oil, 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 at www.gethalls.com>

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

<NDC 12546-115-30 Halls Tropical Fruit 30ct Bag>

MM1MM1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
MENTHOLACTIVE MOIETYL7T10EIP3A2
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7J2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6622
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FF2
SUCROSEINACTIVE INGREDIENTC151H8M5542
WATERINACTIVE INGREDIENT059QF0KO0R2

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
12546-11512546-115-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-CAROTENE01YAE03M7JIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62POWDER, FOR SUSPENSION / ORAL39 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASPONGE / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
BETA CAROTENEBETA CAROTENE01YAE03M7JCREAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSOLUTION / ORAL913 mgExact identifier — unii candidate
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
BETA CAROTENEBETA CAROTENE01YAE03M7JEMULSION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii candidate
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
POTASSIUM CITRATEPOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates

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
d3979f31-858b-49ac-e053-2995a90a2cad57007dcc-46bb-4615-aa68-a9c6b20b57a22021-12-20WarningsExact identifier
spl id: d3979f31-858b-49ac-e053-2995a90a2cad
spl set id: 57007dcc-46bb-4615-aa68-a9c6b20b57a2

Reported adverse events (FAERS/openFDA)#

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