HALLS EXTRA STRONG MENTHOL- menthol lozenge 
Mondelēz Group 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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Active Ingredient

<(in each drop) Menthol 15 mg>

Purposes

<Oral anesthetic>

Uses

<temporarily relieves occasional minor irritation and pain associated with>

  • sore throat
  • sore mouth

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.>

Stop use and ask a doctor if

  • sore mouth does not improve in 7 days
  • irritation, pain , or redness persists or worsens

Keep out of reach of children

Enter section text here

Directions

  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other information

  • 12 calories per drop
  • Contains: SOY

Inactive ingredients

<citric acid, eucalyptus oil, FDC blue 1, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

Questions

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

Package Principal Display Panel

Enter sOTC PDPection text hereNDC 12546-311-30 Halls Extra Strong Menthol 30 drop bag

HALLS  EXTRA STRONG MENTHOL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-311
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol15 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
POTASSIUM CITRATE 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorwhite (white with blue specks) Scoreno score
ShapeOVALSize21mm
FlavorMENTHOL (Extra Strong Menthol) Imprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-311-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2013
Labeler - Mondelēz Group LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelēz Canada Inc.246791201manufacture(12546-311)

Revised: 05/2013
 
Mondelēz Group LLC