HALLS APPLE CIDER- 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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Drug Facts

Active ingredient

<(in each drop) Menthol 5.7 mg>

Purposes

<Cough suppressant, Oral anesthetic>

Uses

<temporarily relieves:>

Warnings

<Sore throat warnings:  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.


Directions

Other information

Inactive ingredients

<beta carotene, caramel color, FDandC blue 1, FDandC red40, FDandC yellow 5 , flavors, glucose syrup, glycerin, malic acid, partially hydrogentated cottonseed oil, 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

<NDC 12546-106-20 Halls Warm Ups Apple Cider 20 Drops Bag>

OTC Principal Display Panel
HALLS  APPLE CIDER
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.7 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALIC ACID (UNII: 817L1N4CKP)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorAPPLE (APPLE CIDER FLAVOR) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-106-2020 in 1 BAG
2NDC:12546-106-022 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/23/2013
Labeler - Mondelez Global LLC (050964956)

Revised: 7/2013
Document Id: 5244bae0-f702-40ee-9fc8-77db41ecf51f
Set id: 2bf87c75-c988-4937-92fe-9400e5fab8e2
Version: 3
Effective Time: 20130723
 
Mondelez Global LLC