Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

HALLS HONEY LEMON- 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.

----------

Drug Facts

Active ingredient

<(per drop) Menthol 7.5 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 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

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

  • 10 calories per drop
  • Contains:  SOY.

Inactive ingredients

<beta carotene, eucalyptus oil, flavors, glucose syrup, honey, soy lecithin, sucralose, sucrose, water>

Questions

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

OTC Principal Display Panel

<NDC: 12546-110-30 Halls Honey Lemon 30ct bag>

MM1

HALLS  HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 12546-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
.BETA.-CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HONEY (UNII: Y9H1V576FH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeOVALSize21mm
FlavorHONEY (HONEY LEMON) Imprint Code H
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 12546-110-1818 in 1 BAG; Type 0: Not a Combination Product03/24/2019
2NDC: 12546-110-3030 in 1 BAG; Type 0: Not a Combination Product03/24/2019
3NDC: 12546-110-2424 in 1 BAG; Type 0: Not a Combination Product12/02/2019
4NDC: 12546-110-4040 in 1 BAG; Type 0: Not a Combination Product03/24/2019
5NDC: 12546-110-8080 in 1 BAG; Type 0: Not a Combination Product03/24/2019
6NDC: 12546-110-1616 in 1 BAG; Type 0: Not a Combination Product03/24/2019
7NDC: 12546-110-9696 in 1 BAG; Type 0: Not a Combination Product03/24/2019
8NDC: 12546-110-1414 in 1 PACKAGE; Type 0: Not a Combination Product03/24/2019
9NDC: 12546-110-99160 in 1 BAG; Type 0: Not a Combination Product03/24/2019
10NDC: 12546-110-02150000 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product12/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/24/2019
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIBusiness Operations
Express Packaging of Ohio, Inc.147558563repack(12546-110)

Revised: 12/2019
 
Mondelez Global LLC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.