HALLS  BREEZERS SUGAR FREE 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 sugar free Cool Berry

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


Directions

Other information

Inactive ingredients

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

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

OTC Principal Display Panel

<NDC 12546-720-20 Halls SF Cool Berry 20ct bag>

HALLS   BREEZERS SUGAR FREE COOL BERRY
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-720
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
MALIC ACID (UNII: 817L1N4CKP)  
MALTITOL (UNII: D65DG142WK)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (red and white) Scoreno score
ShapeOVALSize21mm
FlavorBERRY (Cool Berry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-720-2020 in 1 BAG; Type 0: Not a Combination Product05/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/27/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-720)

Revised: 3/2023
Document Id: f75c4b87-3007-a938-e053-6394a90ac4cb
Set id: dd1b4b17-4f73-4052-9589-d5fd6bb059bb
Version: 6
Effective Time: 20230320
 
Mondelez Global LLC