HALLS HONEY VANILLA- 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 Honey Vanilla

Active Ingredient

<(per drop) Menthol 2.5 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 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

Directions

Other information

Inactive ingredients

<beta carotene, flavors, glucose syrup, honey, 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

<NDC 12546-338-30 Halls Honey Vanilla 30ct bag>

HALLS  HONEY VANILLA
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-338
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize21mm
FlavorHONEY (Honey Vanilla) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-338-3030 in 1 BAG; Type 0: Not a Combination Product03/05/2019
2NDC:12546-338-8080 in 1 BAG; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/05/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-338)

Revised: 3/2023
Document Id: f75c1f5a-4a1e-0e71-e053-6294a90a8122
Set id: 8e94a1b8-8915-4595-b097-8a0a319d54aa
Version: 9
Effective Time: 20230320
 
Mondelez Global LLC