HALLS MOCHA MINT- menthol lozenge 
Kraft Foods Global, Inc.

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 5 mg

Purposes

Cough Suppressant, Oral Anesthetic

Uses

  • cough due to a cold
  • occasional minor irritation or sore throat

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

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persist 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

  • 15 calories per drop
  • contains: soy

Inactive ingredients

caramel color, FDC blue 1, FDC red 40, FDC yellow 5 (tartrazine), flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, soy lecithin, sucrose, water

Questions

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

OTC Principal Display Panel

NDC 12546-105-20 Halls Warm Ups Mocha Mint 20 drops bag
OTC Principal Display Panel
HALLS  MOCHA MINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
GLYCERIN 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorMINT (MOCHA MINT FLAVOR) Imprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-105-2020 in 1 BAG
2NDC:12546-105-022 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/11/2011
Labeler - Kraft Foods Global, Inc. (039010590)
Establishment
NameAddressID/FEIBusiness Operations
Kraft Canada Inc.246791201manufacture

Revised: 04/2011
Document Id: 37fe7e44-090f-41b4-a783-f312357f420e
Set id: c2c7ee70-19bb-4f45-afd3-970836b1e99b
Version: 2
Effective Time: 20110429
 
Kraft Foods Global, Inc.