HALLS  ICE PEPPERMINT- menthol lozenge 
Cadbury Adams USA 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 10 mg

Purposes

Cough suppressant, Oral anesthetic

temporarily relieves:
  • 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 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

  • 15 calories per drop

Inactive ingredients

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 at www.gethalls.com

OTC Principal Display Panel

NDC

12546-101-09

Halls Ice Peppermint

9 Drop Stick

OTC Principal Display Panel 9 Stick

HALLS   ICE PEPPERMINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol10 mg
Product Characteristics
Colorblue (aqua with blue glitter) Scoreno score
ShapeSQUARE (square) Size4mm
FlavorPEPPERMINT (Ice Peppermint) Imprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-101-099 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/2010
Labeler - Cadbury Adams USA LLC (133306352)

Revised: 04/2010
 
Cadbury Adams USA LLC