HALLS SUGAR FREE CITRUS BLEND- 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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SF citrus blend

Active Ingredient

<(per drop) Menthol 5 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:

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.>

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children

Enter section text here

Directions

Other information

Inactive ingredients

<acesulfame potassium, aspartame, beta carotene, eucalyptus oil, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Questions

<Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com>

OTC Principal Display Panel

<NDC 12546-613-25 Halls SF Citrus Blend 25ct bag>

MM1

HALLS  SUGAR FREE CITRUS BLEND
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-613
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ISOMALT (UNII: S870P55O2W)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (light yellow) Scoreno score
ShapeOVALSize21mm
FlavorCITRUS (CITRUS BLEND) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-613-2525 in 1 BAG; Type 0: Not a Combination Product07/14/2019
2NDC:12546-613-7070 in 1 BAG; Type 0: Not a Combination Product07/14/201904/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-613)

Revised: 9/2022
Document Id: e9c324a9-f38e-4896-e053-2a95a90a2cb9
Set id: 65852200-8610-41cd-b206-4f387c5e2ec7
Version: 7
Effective Time: 20220928
 
Mondelez Global LLC