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.

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Drug Facts

Active ingredient

<(in each 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

  • 12 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 atwww.gethalls.com>

OTC Principal Display Panel

<Halls Honey Lemon 40 drops bag NDC 12546-110-40>MM1

HALLS  HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12546-110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
EUCALYPTUS OIL 
HONEY 
LECITHIN, SOYBEAN 
SUCRALOSE 
SUCROSE 
WATER 
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
2NDC:12546-110-3030 in 1 BAG
3NDC:12546-110-4040 in 1 BAG
4NDC:12546-110-8080 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2013
Labeler - Mondelez Global LLC (050964956)

Revised: 3/2013
 
Mondelez Global LLC