BREEZERS COOL BERRY- 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 cool berry bag

Active Ingredient

<(per drop) Pectin 7 mg>

Purpose

<Oral demulcent>

Uses

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

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

Keep out of reach of children

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

Directions

Other information

<

Inactive ingredients

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

Questions

<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

Halls cool berry 25ct

BREEZERS  COOL BERRY
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALIC ACID (UNII: 817L1N4CKP)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
CORN SYRUP (UNII: 9G5L16BK6N)  
Product Characteristics
Colorred (red with white stripe) Scoreno score
ShapeOVALSize22mm
FlavorBERRY (Cool Berry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-151-2525 in 1 BAG; Type 0: Not a Combination Product03/24/2019
2NDC:12546-151-7070 in 1 BAG; Type 0: Not a Combination Product03/24/2019
3NDC:12546-151-3030 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/24/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-151)

Revised: 10/2022
Document Id: ea3ca133-520f-3207-e053-2995a90a04bb
Set id: b31d0078-21d7-4d18-a8d3-7c8d48d6d004
Version: 6
Effective Time: 20221004
 
Mondelez Global LLC