HALLS PLUS STRAWBERRY- 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.

----------

Drug Facts

Active Ingredient

<(in each drop) Menthol 2.7 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

Enter section text here

Directions

Other information

Inactive ingredients

<FDC red40, flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, potassium citrate, 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 12546-985-25 and CA NDC 67238-985-25 Halls Plus Icy Syrup Center Strawberry Flavor 25 drops bag>

HALLS  PLUS STRAWBERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-985
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol2.7 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (Red) Scoreno score
ShapeOVALSize22mm
FlavorSTRAWBERRY (Plus Strawberry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-985-2525 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(12546-985)

Revised: 7/2013
Document Id: 08109a1f-5071-4c8c-b7f0-8de7e1dd0f0b
Set id: 0668ff79-320d-4a77-9f7c-5e0407d190e6
Version: 1
Effective Time: 20130725
 
Mondelez Global LLC