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Halls Mentholyptus by Mondelēz Global LLC

Medically reviewed on November 14, 2016

Dosage form: lozenge
Ingredients: Menthol 6.4mg
Labeler: Mondelēz Global LLC
NDC Code: 12546-334

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 6.4 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 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
  • 15 calories per drop
  • Contains:  SOY.

Inactive ingredients

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, 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 12546-334-09 Halls Mentho-Lyptus Stick 9ct>

HALLS  MENTHOLYPTUS
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-334
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol6.4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
eucalyptus oil 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
POTASSIUM CITRATE 
LECITHIN, SOYBEAN 
sucrose 
water 
Product Characteristics
Colorwhite (white with blue specks) Scoreno score
ShapeSQUARESize21mm
FlavorMENTHOL (Mentholyptus) Imprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-334-0909 LOZENGE in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/14/2016
Labeler - Mondelēz Global LLC (050964956)
Establishment
NameAddressID/FEIOperations
Mondelēz Canada Inc.246791201manufacture(12546-334)

 
Mondelēz Global LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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