HALLS KIDS HONEY APPLE- menthol lozenge 
Mondelez Global LLC

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HALLS Kids Pop Honey Apple

Active Ingredient

<(per pop) Menthol 5 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 by fever, headache, rash, swelling, 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 1 pop slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor

Other information

  • 25 calories per pop

Inactive ingredients

<flavors, glucose syrup, honey, 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 12546-350-10 Halls Kids Honey Apple Bag 10 ct>

MM1

HALLS KIDS  HONEY APPLE
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
HONEY (UNII: Y9H1V576FH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (pale yellow) Scoreno score
ShapeROUNDSize20mm
FlavorHONEY (Honey Apple) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12546-350-1010 in 1 BAG; Type 0: Not a Combination Product03/30/202006/21/2024
2NDC:12546-350-1110 in 1 CARTON; Type 0: Not a Combination Product03/30/202006/21/2024
3NDC:12546-350-01800 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/202005/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/30/202006/21/2024
Labeler - Mondelez Global LLC (091849786)
Establishment
NameAddressID/FEIBusiness Operations
BestCo Inc.002149136manufacture(12546-350)

Revised: 6/2024
 
Mondelez Global LLC