HALLS SUGAR FREE BLACK CHERRY- 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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Drug Facts

Active Ingredient

(in each drop) Menthol 5.8 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 1 drop slowly in the mouth.  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, 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

NDC 12546-104-25 Halls Sugar Free Black Cherry 25 drops bag
OTC Principal Display Panel
HALLS  SUGAR FREE BLACK CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12546-104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol5.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
ISOMALT 
LECITHIN, SOYBEAN 
WATER 
Product Characteristics
Colorred (dark red) Scoreno score
ShapeOVALSize21mm
FlavorCHERRY (Black Cherry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-104-2525 in 1 BAG
2NDC:12546-104-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/27/2011
Labeler - Kraft Foods Global, Inc. (039010590)

Revised: 7/2011
 
Kraft Foods Global, Inc.