HALLS BUTTERSCOTCH- 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

<beta carotene, caramel color, 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

OTC PDPEnter section text here<USNDC 12546-108-20 and CA NDC 67238-108-20 Halls Warm Ups Butterscotch 20 drops bag>

HALLS  BUTTERSCOTCH
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CARAMEL (UNII: T9D99G2B1R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorBUTTERSCOTCH (BUTTERSCOTCH FLAVOR) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-108-2020 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2011
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-108)

Revised: 7/2013
Document Id: 9fec7127-f1bc-445c-a0a9-77cedd87f185
Set id: 9a2a7771-1fc0-4999-977b-fa1c02f8ce34
Version: 2
Effective Time: 20130725
 
Mondelez Global LLC