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Halls Spearmint by Mondelez Global LLC

Dosage form: lozenge
Ingredients: MENTHOL 4.6mg
Labeler: Mondelez Global LLC
NDC Code: 12546-113

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

<(in each drop) Menthol 4.6 mg>

Purposes

<Cough Suppressant, Oral Anesthetic>

Uses

<temporarily relieves:>

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings

<Sore throat warnings: if sore throat is severe, persist 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 berfore 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 persist 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
  • 12 calories per drop
  • contains: SOY

Inactive ingredients

<beta carotene, eucalyptus oil, FDC blue 1, flavors, glucose syrup, 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

<Halls Spearmint 30 drops bag NDC 12546-113-30>

HALLS  SPEARMINT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.6 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
EUCALYPTUS OIL 
FD&C BLUE NO. 1 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorgreen (light green) Scoreno score
ShapeOVALSize21mm
FlavorSPEARMINTImprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-113-3030 LOZENGE (LOZENGE) 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: 04/2013
 
Mondelez Global LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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