HALLS 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.

----------

HALLS HONEY LEMON bag

Active ingredient

<(per drop) Menthol 7.5 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 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, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

Questions

<Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

Halls Honey lemon 30ct

HALLS  HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeOVALSize21mm
FlavorHONEY (HONEY LEMON) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-110-1818 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
2NDC:12546-110-3030 in 1 BAG; Type 0: Not a Combination Product03/24/2019
3NDC:12546-110-2424 in 1 BAG; Type 0: Not a Combination Product12/02/201906/11/2023
4NDC:12546-110-4040 in 1 BAG; Type 0: Not a Combination Product03/24/201907/22/2023
5NDC:12546-110-8080 in 1 BAG; Type 0: Not a Combination Product03/24/2019
6NDC:12546-110-1616 in 1 BAG; Type 0: Not a Combination Product03/24/201909/16/2022
7NDC:12546-110-9696 in 1 BAG; Type 0: Not a Combination Product03/24/201904/21/2020
8NDC:12546-110-1414 in 1 PACKAGE; Type 0: Not a Combination Product03/24/2019
9NDC:12546-110-99160 in 1 BAG; Type 0: Not a Combination Product03/24/2019
10NDC:12546-110-02150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
11NDC:12546-110-032400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
12NDC:12546-110-04720 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/201909/16/2022
13NDC:12546-110-00250 in 1 JAR; Type 0: Not a Combination Product07/06/2022
14NDC:12546-110-01140 in 1 BAG; Type 0: Not a Combination Product04/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01203/24/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-110)

Revised: 7/2023
Document Id: 00ed4b55-cedc-219d-e063-6294a90ac32d
Set id: aec46410-ffb1-4db4-b232-82110c562f69
Version: 17
Effective Time: 20230720
 
Mondelez Global LLC