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Halls Ice Peppermint by Mondelēz Global LLC

Dosage form: lozenge
Ingredients: Menthol 10mg
Labeler: Mondelēz Global LLC
NDC Code: 12546-101

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.

Drug Facts

Active ingredient

<(per 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.

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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

<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 9ct 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
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorblue (aqua with blue glitter) Scoreno score
ShapeSQUARE (square) Size21mm
FlavorPEPPERMINT (Ice Peppermint) Imprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-101-099 LOZENGE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/21/2016
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIOperations
Mondelēz Canada Inc.246791201manufacture(12546-101)

 
Mondelēz Global LLC

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Medically reviewed on Nov 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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