HALLS HONEY- 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 Honey Bag (take 2)

Active Ingredient

<(in each drop) Menthol 2.7 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:

  •  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 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
  • contains: soy>

Inactive ingredients

<FDC Blue 1, FDC Red 40, FDC Yellow 5 (tartrazine), flavors, glucose syrup, honey, 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 12546-317-30 Halls Honey 30 ct Bag> MM1

HALLS  HONEY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.7 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeOVALSize21mm
FlavorHONEYImprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-317-3030 in 1 BAG; Type 0: Not a Combination Product05/01/2015
2NDC:12546-317-4040 in 1 BAG; Type 0: Not a Combination Product05/01/2015
3NDC:12546-317-8080 in 1 BAG; Type 0: Not a Combination Product05/01/2015
4NDC:12546-317-022 in 1 BAG; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/201512/20/2020
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Mondelez Canada Inc246791201manufacture(12546-317)

Revised: 1/2022
 
Mondelez Global LLC