BREEZERS CREAMY STRAWBERRY- pectin lozenge 
Mondelez Global LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Halls Breezers creamy strawberry

Active Ingredient

<(per drop) Pectin 7 mg>

Purpose

<Oral demulcent>

Uses

<temporarily relieves the following symptoms associated with sore mouth and sore throat: •minor discomfort • irritated areas>

Warnings

<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

<•sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens>

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

<•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

<•15 calories

• Contains: SOY.>

Inactive ingredients

<beta carotene, citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, lactic acid, malic acid, potassium citrate, sodium chloride, soy lecithin, sucrose, titanium dioxide, water>

Questions

<Call 1-800-524-2854, Monday to Friday, 9AM-5PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

Halls creamy strawberry 25ct

BREEZERS  CREAMY STRAWBERRY
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-352
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTIC ACID (UNII: 33X04XA5AT)  
MALIC ACID (UNII: 817L1N4CKP)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White with red stripe) Scoreno score
ShapeOVALSize22mm
FlavorSTRAWBERRY (Creamy Strawberry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-352-2525 in 1 BAG; Type 0: Not a Combination Product03/13/2019
2NDC:12546-352-3030 in 1 BAG; Type 0: Not a Combination Product03/13/201909/16/2022
3NDC:12546-352-7070 in 1 BAG; Type 0: Not a Combination Product05/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/03/2016
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-352)

Revised: 10/2022
Document Id: ea3be7a5-f72b-22c0-e053-2995a90a9fc3
Set id: 777fd6db-f129-4489-8312-4b1aca94878e
Version: 8
Effective Time: 20221004
 
Mondelez Global LLC