HALLS SUGAR FREE BLACK CHERRY- menthol lozenge 
Mondelēz Global 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.

----------

Drug Facts

Active ingredient

<(in each drop) Menthol 6.6mg>

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
  • 5 calories per drop
  • Contains:  SOY

Inactive ingredient

<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, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

Enter section text here NDC 12546-103-09 Halls Sugar Free Black Cherry 9 drops packageOTC Principal Display Panel 9 stick

HALLS  SUGAR FREE BLACK CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol6.6 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (dark red) Scoreno score
ShapeSQUARESize21mm
FlavorCHERRY (Black Cherry) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-103-099 in 1 PACKAGE; Type 0: Not a Combination Product10/01/201307/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/201307/19/2018
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelēz Canada Inc.246791201manufacture(12546-103)

Revised: 10/2017
 
Mondelēz Global LLC