HALLS SUGAR FREE HONEY BERRY- 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 2.5 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 slowly in the mouth (one at a time).  Repeat every 2 hours as needed
  • children under 5 years: ask a doctor

Other information

  • phenylketonurics: contains phenylalanine 2 mg per drop
  • excessive consumption may have a laxative effect
  • 5 calories per drop
  • contains soy

Inactive ingredients

acesulfame potassium, aspartame, beta carotene, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water

Questions

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

OTC Principal Display Panel

Enter section text here     12546-223-25  Halls Sugar Free Honey Berry 25 drops bag   OTC PDP

HALLS  SUGAR FREE HONEY BERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-223
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol2.5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
BETA CAROTENE 
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
ISOMALT 
CARBOXYMETHYLCELLULOSE SODIUM 
LECITHIN, SOYBEAN 
WATER 
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeOVALSize21mm
FlavorCITRUS (CITRUS BLEND) Imprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-223-2525 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2012
Labeler - Kraft Foods Global, Inc. (039010590)

Revised: 01/2012
 
Kraft Foods Global, Inc.