HALLS SUGAR FREE BLACK CHERRY- menthol 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 black cherry bag

Active Ingredient

<(per drop) Menthol 5.8 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:

Warnings

<Sore throat warning: if sore throat is severe, persist 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.>

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

Enter section text here

Directions

Other information


Inactive ingredients

<acesulfame potassium, aspartame, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, 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

Halls sugar free black cherry 70ct

HALLS  SUGAR FREE BLACK CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (dark red) Scoreno score
ShapeOVALSize21mm
FlavorCHERRY (Black Cherry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-104-2525 in 1 BAG; Type 0: Not a Combination Product06/10/2019
2NDC:12546-104-3030 in 1 BAG; Type 0: Not a Combination Product06/10/201906/21/2022
3NDC:12546-104-7070 in 1 BAG; Type 0: Not a Combination Product06/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/10/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-104)

Revised: 10/2022
Document Id: ea3bfe4a-2b51-2a12-e053-2995a90af14f
Set id: bd2a311a-bf0c-4365-af9b-76675c243b22
Version: 7
Effective Time: 20221004
 
Mondelez Global LLC