Halls Apple Cider

Dosage form: lozenge
Ingredients: Menthol 5.7mg
Labeler: Mondelez Global LLC
NDC Code: 12546-106

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 5.7 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, 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.

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

<beta carotene, caramel color, FDandC blue 1, FDandC red40, FDandC yellow 5 , flavors, glucose syrup, glycerin, malic acid, partially hydrogentated cottonseed oil, 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 12546-106-20 Halls Warm Ups Apple Cider 20 Drops Bag>

HALLS  APPLE CIDER
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol5.7 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
CARAMEL  
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 5 
GLYCERIN 
MALIC ACID 
POTASSIUM CITRATE 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorAPPLE (APPLE CIDER FLAVOR) Imprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-106-2020 LOZENGE (LOZENGE) in 1 BAG
2NDC:12546-106-022 LOZENGE (LOZENGE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/23/2013
Labeler - Mondelez Global LLC (050964956)

Revised: 07/2013
 
Mondelez Global LLC

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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