HALLS SUGAR FREE MOUNTAIN MENTHOL- menthol lozenge 
Mondelez Global LLC

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HALLS Sugar Free Mountain Menthol

Active Ingredient

<(per 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 warnings:  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 - 6 PM Eastern Time or visit our website atwww.gethalls.com>

OTC Principal Display Panel

<NDC 12546-640-25 Halls SF Mountain Menthol 70 ct bag>

HALLS  SUGAR FREE MOUNTAIN MENTHOL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-640
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 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)  
ISOMALT (UNII: S870P55O2W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeOVALSize21mm
FlavorMENTHOL (MOUNTAIN MENTHOL) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-640-2525 in 1 BAG; Type 0: Not a Combination Product06/03/201906/21/2024
2NDC:12546-640-7070 in 1 BAG; Type 0: Not a Combination Product06/03/2019
3NDC:12546-640-99250 in 1 JAR; Type 0: Not a Combination Product09/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/03/2019
Labeler - Mondelez Global LLC (091849786)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-640)

Revised: 12/2023
 
Mondelez Global LLC