HALLS SUGAR FREE HONEY LEMON- 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 SF honey lemon bag

Active Ingredient

<(per drop) Menthol 7.6 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:

Warnings

<Sore throat warnings:  if sore throat is severe, persist 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

<beta carotene, eucalyptus oil, flavors, isomalt, soy lecithin, sucralose, 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

Halls sugar free honey lemon 25ct

HALLS  SUGAR FREE HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-642
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ISOMALT (UNII: S870P55O2W)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeOVALSize21mm
FlavorLEMON (HONEY LEMON) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-642-2525 in 1 BAG; Type 0: Not a Combination Product05/27/2019
2NDC:12546-642-3030 in 1 BAG; Type 0: Not a Combination Product05/27/201905/21/2023
3NDC:12546-642-79180 in 1 BAG; Type 0: Not a Combination Product05/27/2019
4NDC:12546-642-7070 in 1 BAG; Type 0: Not a Combination Product05/27/2019
5NDC:12546-642-022 in 1 BAG; Type 0: Not a Combination Product05/27/201905/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-642)

Revised: 10/2022
Document Id: ea3cc5d1-453d-1e81-e053-2995a90a3509
Set id: 2b19fdd2-8088-47f2-be20-f220a6b825fc
Version: 8
Effective Time: 20221004
 
Mondelez Global LLC