HALLS MOCHA MINT- 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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Drug Facts

Active Ingredient

<(in each drop) Menthol 5 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

Enter section text here

Directions

Other information

Inactive ingredients

<caramel color, FDC blue 1, FDC red 40, FDC yellow 5 (tartrazine), flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, soy lecithin, sucrose, 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

<NDC 12546-105-20 Halls Warm Ups Mocha Mint 20 drops bag>

OTC Principal Display Panel
HALLS  MOCHA MINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorMINT (MOCHA MINT FLAVOR) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-105-2020 in 1 BAG
2NDC:12546-105-022 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2013
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-105)

Revised: 8/2013
Document Id: b6da0e76-e3b4-4a7e-bbfe-807b0cd1caa3
Set id: c2c7ee70-19bb-4f45-afd3-970836b1e99b
Version: 3
Effective Time: 20130801
 
Mondelez Global LLC