HALLS KIDS STRAWBERRY- 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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Drug Facts

Active Ingredient

<(per pop) Menthol 5 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:>

Warnings

<Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, 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

Directions

Other information

Inactive ingredients

<citric acid, FD&C red 40, flavors, glucose syrup, potassium citrate, sucrose, water>

Questions

<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 12546-337-10 Halls Kids Strawberry 10ct Bag>

MM1

HALLS KIDS  STRAWBERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-337
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize20mm
FlavorSTRAWBERRYImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-337-1010 in 1 BAG; Type 0: Not a Combination Product07/26/2019
2NDC:12546-337-1110 in 1 CARTON; Type 0: Not a Combination Product08/05/2019
3NDC:12546-337-011 in 1 BAG; Type 0: Not a Combination Product07/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/26/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
BestCo Inc.002149136manufacture(12546-337)

Revised: 8/2019
Document Id: 88324602-3abf-44aa-8a69-51da4f8968dd
Set id: f1eaafe3-2065-4961-af03-bb6bcea331a3
Version: 6
Effective Time: 20190805
 
Mondelez Global LLC