HALLS EXTRA STRONG MENTHOL 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

<(per drop) Menthol 20 mg>

Purposes

<Oral anesthetic>

Uses

<temporarily relieves occasional minor irritation and pain associated with:>

-sore throat

-sore mouth

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.>

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other Information

Inactive Ingredients

<citric acid, eucalyptus oil, FD&C blue 1, flavors, glucose syrup, potassium citrate, 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

<NDC12546-341-30 Halls Extra Strong Menthol Flavor 30ct Bag> image description

HALLS  EXTRA STRONG MENTHOL MENTHOL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White with blue specks) Scoreno score
ShapeOVALSize21mm
FlavorMENTHOL (Extra Strong Menthol) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-341-3030 in 1 BAG; Type 0: Not a Combination Product07/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/26/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-341)

Revised: 5/2021
Document Id: c17476b6-8794-b079-e053-2995a90aa49c
Set id: 4e957066-028f-4e25-b832-3b3c6ef280ba
Version: 3
Effective Time: 20210503
 
Mondelez Global LLC