HALLS BUTTERSCOTCH- menthol lozenge 
Mondelez Global LLC

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Halls Warm Ups

Active Ingredient

<(in each drop) Menthol 5 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

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

Warnings

<Sore throat warning: if sore throat is severe, persists 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

  • 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 persists 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 persist or worsens

Keep out of reach of children

Enter section text here

Directions

  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed
  • children under 5 years: ask a doctor

Other information

  • 15 calories per drop
  • contains: soy

Inactive ingredients

<beta carotene, caramel color, flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, soy lecithin, sucrose, water>

Questions

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

OTC Principal Display Panel

OTC PDPEnter section text here<USNDC 12546-108-20 and CA NDC 67238-108-20 Halls Warm Ups Butterscotch 20 drops bag>

HALLS  BUTTERSCOTCH
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CARAMEL (UNII: T9D99G2B1R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorBUTTERSCOTCH (BUTTERSCOTCH FLAVOR) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-108-2020 in 1 BAG; Type 0: Not a Combination Product12/01/201106/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/01/201106/30/2015
Labeler - Mondelez Global LLC (091849786)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-108)

Revised: 12/2024
 
Mondelez Global LLC