HALLS SPEARMINT- 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 Spearmint 30ct Bag

Active Ingredient

<(per drop) Menthol 4.6 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:>

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings

<Sore throat warnings: 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 berfore use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • cough persist for more than 1 week, tends to recur,or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition.
  • 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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other Information

  • 10 calories per drop
  • Contains: SOY.

Inactive ingredients

<beta carotene, eucalyptus oil, FDC blue 1, flavors, glucose syrup, soy lecithin, 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 12546-113-30 Halls Spearmint 30ct Bag> MM1

HALLS  SPEARMINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorgreen (light green) Scoreno score
ShapeOVALSize21mm
FlavorSPEARMINTImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-113-3030 in 1 BAG; Type 0: Not a Combination Product11/07/201603/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/07/201603/16/2021
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc.246791201manufacture(12546-113)

Revised: 12/2021
 
Mondelez Global LLC