HALLS SPEARMINT- 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 4.6 mg

Purposes

Cough Suppressant, Oral Anesthetic

Uses

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

Warnings

Sore throat warning:  if sore throat is severe, persist 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 persists or worsens

Keep out of reach of children

Enter section text here

Directions

  • adults and children 5 years and over:  dissolve 2 drops (one at a time) 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

beta catrotene, eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, sucrose, water

Questions

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

OTC Principal Display Panel

image descriptionOTC PDPNDC 12546-113-30 Halls Spearmint 30 drops bag

HALLS  SPEARMINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.6 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorgreen (light green) Scoreno score
ShapeOVALSize21mm
FlavorSPEARMINTImprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-113-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2012
Labeler - Kraft Foods Global, Inc. (039010590)

Revised: 03/2012
 
Kraft Foods Global, Inc.