HALLS KIDS  HONEY APPLE- 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 Kids Honey Apple

Active Ingredient

(per pop) Menthol 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

flavors, glucose syrup, honey, 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 12546-350-10 Halls Kids Honey Apple Bag 10 ct>

MM1

HALLS KIDS   HONEY APPLE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
HONEY (UNII: Y9H1V576FH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (pale yellow) Scoreno score
ShapeROUNDSize20mm
FlavorHONEY (Honey Apple) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-350-1010 in 1 BAG; Type 0: Not a Combination Product03/30/2020
2NDC:12546-350-1110 in 1 CARTON; Type 0: Not a Combination Product03/30/2020
3NDC:12546-350-01800 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/202005/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2020
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
BestCo Inc.002149136manufacture(12546-350)

Revised: 11/2021
Document Id: d2088c9e-d518-a36d-e053-2995a90a08e7
Set id: 15929a49-09c5-4f46-bdde-95c56b2578a1
Version: 3
Effective Time: 20211130
 
Mondelez Global LLC