Halls

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 00:47:58

Label at a glance#

ProductHalls Breezers Sugar Free Cool Berry

Active ingredientPECTIN

Label structure10 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

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

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, water

Questions

OTC - QUESTIONS SECTION

OTC Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1242251	Halls Breezers 7 MG Oral Lozenge	PSN	7
700897	pectin 7 MG Oral Lozenge	PSN	7
1242251	pectin 7 MG Oral Lozenge [Halls Breezers]	SBD	7
700897	pectin 7 MG Oral Lozenge	SCD	7
1242251	Halls Breezers 7 MG Oral Lozenge	SY	7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12546-720-20	HallsBreezers Sugar Free Cool Berry	20 in 1 BAG	LOZENGE	20		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12546-720	HALLS BREEZERS SUGAR FREE COOL BERRY (PECTIN) LOZENGE [MONDELEZ GLOBAL LLC]	7	Current NDC, Legacy NDC, 1 package rows	20241222_dd1b4b17-4f73-4052-9589-d5fd6bb059bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pectin	ACTIVE INGREDIENT	89NA02M4RX	2
Pectin	ACTIVE MOIETY	89NA02M4RX	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	2
MALIC ACID	INACTIVE INGREDIENT	817L1N4CKP	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Halls Breezers Sugar Free Cool Berry
Pectin
ACESULFAME POTASSIUM
ASPARTAME
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 2
FD&C RED NO. 40
ISOMALT
MALIC ACID
MALTITOL
POTASSIUM CITRATE
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
12546-720	12546-720-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ASPARTAME	Z0H242BBR1	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ISOMALT	S870P55O2W	IACT
MALIC ACID	817L1N4CKP	IACT
MALTITOL	D65DG142WK	IACT
POTASSIUM CITRATE	EE90ONI6FF	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
PECTIN	89NA02M4RX	ACTIB

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 · 228 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 44 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	CAPSULE / ORAL		155 mg	Exact identifier — unii+route 10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	TABLET / ORAL		20 mg	Exact identifier — unii+route 10 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 44 equally ranked IID candidates
MALIC ACID	MALIC ACID	817L1N4CKP	POWDER, FOR SOLUTION / ORAL		1230 mg	Exact identifier — unii+route 10 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
ISOMALT	ISOMALT	S870P55O2W	TABLET, CHEWABLE / ORAL		630 mg	Exact identifier — unii+route 8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii+route 36 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii+route 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii+dosage form 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii+route 44 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii+dosage form 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE / ORAL		4 mg	Exact identifier — unii+route 18 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii+route 10 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route 36 equally ranked IID candidates
ISOMALT	ISOMALT	S870P55O2W	TABLET, CHEWABLE / ORAL		630 mg	Exact identifier — unii+route 8 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii+route 36 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halls Breezers Sugar Free Cool Berry	PECTIN	Mondelez Global LLC	dd1b4b17-4f73-4052-9589-d5fd6bb059bb	2024-12-20	Warnings	Exact identifier ndc (package): 12546-720-20 ndc (product): 12546-720 ndc11 (package): 12546072020 spl id: 29b54da8-f685-6907-e063-6394a90a3061 spl set id: dd1b4b17-4f73-4052-9589-d5fd6bb059bb

Reported adverse events (FAERS/openFDA)#

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