HALLS NATURALS HONEY LEMON CHAMOMILE- 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.

----------

Drug Facts

Active Ingredient

<(in each 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 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

Inactive ingredients

<citric acid, flavors, ginger, glucose syrup, honey, lemon grass, sage, soy lecithin, sucrose, tea extract, water, white thyme>

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

image descriptionMM1

HALLS NATURALS  HONEY LEMON CHAMOMILE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-224
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GINGER (UNII: C5529G5JPQ)  
HONEY (UNII: Y9H1V576FH)  
SAGE (UNII: 065C5D077J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeOVALSize21mm
FlavorHONEY (Honey Lemon Chamomile) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-224-2525 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/07/2013
Labeler - Mondelez Global LLC (050964956)

Revised: 8/2013
Document Id: b55c3f43-cb87-47ff-966b-17aacfd5d273
Set id: bc09d62c-f1be-4a45-8efb-aef436c01631
Version: 1
Effective Time: 20130807
 
Mondelez Global LLC