HALLS SUGAR FREE MENTHO-LYPTUS- 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 minis sugar free mentho-lyptus 24ct

Active ingredient

<(per drop) Menthol 2.7 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. 

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

<acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, isomalt, 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

Halls minis sugar free mentho-lyptus 24ct frontHalls Minis sugar free mentho-lyptus 24ct back

HALLS  SUGAR FREE MENTHO-LYPTUS
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-349
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.7 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorMENTHOL (Mentho-Lyptus) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-349-0311667 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product10/21/202010/03/2022
2NDC:12546-349-2424 in 1 PACKAGE; Type 0: Not a Combination Product10/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/21/2020
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
MSI Express Inc117942991pack(12546-349)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-349)

Revised: 10/2022
Document Id: ea38450c-efbe-7b6a-e053-2995a90a37e4
Set id: 96046858-c57b-426e-8279-91b35e05bcdb
Version: 12
Effective Time: 20221004
 
Mondelez Global LLC