HALLS MENTHO-LYPTUS- 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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Halls mentholyptus bag

Active Ingredient

<(per drop) Menthol 5.4 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:>

Warnings

< Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, 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

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, 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

Halls mentholyptus 30ct

HALLS  MENTHO-LYPTUS
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
CORN SYRUP (UNII: 9G5L16BK6N)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (LIGHT BLUE WITH BLUE SPECKS) Scoreno score
ShapeOVALSize21mm
FlavorMENTHOL (MENTHO-LYPTUS) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-112-3030 in 1 BAG; Type 0: Not a Combination Product04/07/2019
2NDC:12546-112-1414 in 1 BAG; Type 0: Not a Combination Product09/01/202003/21/2023
3NDC:12546-112-4040 in 1 BAG; Type 0: Not a Combination Product04/07/201908/21/2023
4NDC:12546-112-8080 in 1 BAG; Type 0: Not a Combination Product04/07/2019
5NDC:12546-112-89200 in 1 BAG; Type 0: Not a Combination Product04/07/2019
6NDC:12546-112-9696 in 1 BAG; Type 0: Not a Combination Product04/07/201904/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/07/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-112)

Revised: 7/2023
Document Id: 00ed4c30-691f-d7b8-e063-6394a90a31dc
Set id: ff21cf0e-9811-4819-bdfc-17a950e9b114
Version: 9
Effective Time: 20230720
 
Mondelez Global LLC