Breezers

Manufacturer
Mondelez Global LLC | Mondelez Canada Inc
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:47:47

Label at a glance#

ProductBreezers Cool Berry
Active ingredientPECTIN
Label structure11 sections

Dosage and administration

adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth.  Repeat as needed. children under 5 years, ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

<(per drop) Pectin 7 mg>

Purpose

OTC - PURPOSE SECTION

<Oral demulcent>

Uses

INDICATIONS & USAGE SECTION

<temporarily relieves the following symptoms associated with sore mouth and sore throat:

  • minor discomfort
  • irritated areas>

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

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 1 or 2 drops (one at a time) slowly in the mouth.  Repeat 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, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, water>

Questions

OTC - QUESTIONS SECTION

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

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Halls cool berry 25ctHalls cool berry 25ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
700897pectin 7 MG Oral LozengePSN7
700897pectin 7 MG Oral LozengeSCD7

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
12546-151-25BreezersCool Berry25 in 1 BAGLOZENGE257
12546-151-30BreezersCool Berry30 in 1 BAGLOZENGE307
12546-151-70BreezersCool Berry70 in 1 BAGLOZENGE707

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12546-151BREEZERS COOL BERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]7Current NDC, Legacy NDC, 3 package rows20241222_b31d0078-21d7-4d18-a8d3-7c8d48d6d004.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PectinACTIVE INGREDIENT89NA02M4RX2
PectinACTIVE MOIETY89NA02M4RX2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
SUCROSEINACTIVE INGREDIENTC151H8M5542
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12546-15112546-151-25, 12546-151-70, 12546-151-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 7 · 364 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii+route
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii+route
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / ORAL25 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, CHEWABLE / ORAL3 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
88 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, CHEWABLE / ORAL3 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, FILM COATED / ORAL2 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE / ORAL4 mgExact identifier — unii+route
36 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii+route
36 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route
88 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii+route
20 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SOLUTION / ORAL0.33 mg/5mlExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii+route
132 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii+dosage form
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii+route
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii+route
132 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE, DELAYED RELEASE / ORAL0.22 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii+dosage form
132 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET / ORAL8 mgExact identifier — unii+route
20 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii+route
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C BLUE NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / ORAL25 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii+route
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii+route
132 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route
132 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
88 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route
88 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii+route
132 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route
132 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CAPSULE / ORAL20 mgExact identifier — unii+route
20 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
88 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
Breezers Cool BerryPECTINMondelez Global LLCb31d0078-21d7-4d18-a8d3-7c8d48d6d0042024-12-20WarningsExact identifier
ndc (package): 12546-151-30
ndc (package): 12546-151-70
ndc (package): 12546-151-25
ndc (product): 12546-151
ndc11 (package): 12546015125
ndc11 (package): 12546015130
ndc11 (package): 12546015170
spl id: 29b4ca83-7407-7065-e063-6394a90a30ef
spl set id: b31d0078-21d7-4d18-a8d3-7c8d48d6d004

Reported adverse events (FAERS/openFDA)#

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