HALLS EXTRA STRONG MENTHOL MENTHOL- menthol lozenge 
Mondelez Global LLC

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HALLS Max Strenght Extra Strong bag

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

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep out of reach of children

Directions

  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other Information

  • 10 calories per drop
  • Contains: SOY.

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 atwww.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 Product07/26/201906/21/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/26/201906/21/2024
Labeler - Mondelez Global LLC (091849786)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-341)

Revised: 6/2024
 
Mondelez Global LLC