HALLSSUGAR FREE EXTRA  SUGAR FREE EXTRA STRONG MENTHOL- 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 Ingredients

<(in each drop) 18 mg>

Purposes

<Oral Anesthetic>

Uses

<temporarily relieves occasional minor irritation and pain associated with

Warnings

<Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headached, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.>

Stop Use and Ask a Doctor if

Keep out of reach of children

Directions

Other information

Inactive ingredients

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

<Halls Sugar Free Extra Strong Menthol Flavor 9 drops package US NDC 12546-314-09 and CA NDC 67238-314-09>MM1

HALLSSUGAR FREE EXTRA   SUGAR FREE EXTRA STRONG MENTHOL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-314
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL18 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOMALT (UNII: S870P55O2W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (white with blue speckles) Scoreno score
ShapeSQUARESize21mm
FlavorMENTHOL (Sugar Free Extra Strong) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-314-0909 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/04/2014
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-314)

Revised: 2/2014
Document Id: 6ccdfdc8-d6c6-46a0-95c3-c722e1822fe0
Set id: 1c439cb8-e607-483b-b04f-3024524cf2b8
Version: 1
Effective Time: 20140207
 
Mondelez Global LLC