HALLS CHERRY- menthol lozenge 
Mondelēz 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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Drug Facts

Active Ingredient

(in each drop) Menthol 7 mg 

Purposes

Cough Suppressant, Oral Anesthetic

Uses

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

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

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Directions

Other information

Inactive ingredients

eucalyptus oil, FDC blue 2, FDC red 40, flavors, glucose syrup, soy lecithin, sucralose, sucrose, water

Questions

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

OTC Principal Display Panel

Enter section text hereNDC 12546-165-09 Halls Cherry 9 drops packageOTC Principal Display Panel 9 stick

HALLS  CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7 mg
Inactive Ingredients
Ingredient NameStrength
Eucalyptus oil (UNII: 2R04ONI662)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (red) Scoreno score
ShapeSQUARESize21mm
FlavorCHERRY (Cherry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-165-0909 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2013
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelēz Canada Inc.246791201manufacture(12546-165)

Revised: 3/2013
Document Id: 96108f36-1a5f-4981-84d4-67bbd72f8015
Set id: 264c9542-3348-42e0-ae1b-62d4f27b300c
Version: 1
Effective Time: 20130308
 
Mondelēz Global LLC