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Halls Sugar Free Black Cherry by Mondelēz Global LLC

Medically reviewed on October 3, 2016

Dosage form: lozenge
Ingredients: Menthol 6.7mg
Labeler: Mondelēz Global LLC
NDC Code: 12546-330

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 6.7 mg>

Purposes

<Cough suppressant, Oral anesthetic>

Uses
  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings

<Sore throat warning:  if sore throat is sever, 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
  • 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
  • 10 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-6 PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

<NDC 12546-330-09 Halls SF Black Cherry 9ct Stick>

HALLS  SUGAR FREE BLACK CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-330
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol6.7 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
ShapeSQUARESize21mm
FlavorCHERRY (Black Cherry) Imprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-330-099 LOZENGE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/03/2016
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIOperations
Mondelēz Canada Inc.246791201manufacture(12546-330)

 
Mondelēz Global LLC

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Further information

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

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