HALLS SUGAR FREE EXTRA STRONG MENTHOL- menthol lozenge 
Mondelez 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.

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Halls Extra Strong Menthol 25ct Bag

Active Ingredient

<(per drop) 15 mg>

Purpose

<Oral Anesthetic>

Uses

<temporarily relieves occasional minor irritation and pain associated with

  • sore throat
  • sore mouth>

Warnings

<Sore throat warning: 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.>

Stop Use and Ask a Doctor if

  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep out of reach of children.

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

  • phenylaketonurics: contains phenylalanine 2 mg per drop
  • excessive consumption may have a laxative effect
  • 5 calories per drop
  • contains: SOY.

Inactive ingredients

<acesulfame potassium, aspartame, citric acid, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Questons

<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 12546-313-25 Halls SF Extra Strong Menthol Flavor 25ct bag> iMM1

HALLS  SUGAR FREE EXTRA STRONG MENTHOL
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-313
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOMALT (UNII: S870P55O2W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (with blue specks) Scoreno score
ShapeOVALSize21mm
FlavorMENTHOL (Sugar Free Extra Strong Menthol) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-313-2525 in 1 BAG; Type 0: Not a Combination Product09/12/201606/01/2020
2NDC:12546-313-022 in 1 PACKAGE; Type 0: Not a Combination Product09/12/201606/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/12/201606/01/2020
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-313)

Revised: 12/2021
 
Mondelez Global LLC