HALLS SUGAR FREE WATERMELON- 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 Watermelon

Active Ingredient

(per drop) Menthol 2.5 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.

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 red 40, flavors (includes cinnamon), 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

<NDC 12546-351-24 Halls Sugar Free Watermelon 24ct>

<NDC 12546-349-24 Halls Sugar Free Watermelon 24ct<NDC 12546-349-24 Halls Sugar Free Watermelon 24ct

HALLS  SUGAR FREE WATERMELON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize9mm
FlavorWATERMELONImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-351-2424 in 1 PACKAGE; Type 0: Not a Combination Product12/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/13/2021
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
MSI Express, Inc117973852pack(12546-351)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-351)

Revised: 12/2021
Document Id: d2ffefea-cce5-8a29-e053-2995a90acd01
Set id: c4c090ca-f083-74e0-e053-2a95a90a9d60
Version: 2
Effective Time: 20211212
 
Mondelez Global LLC