Halls Butterscotch

Dosage form: lozenge
Ingredients: Menthol 5mg
Labeler: Mondelez Global LLC
NDC Code: 12546-108

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 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 persist 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

<beta carotene, caramel color, flavors, glucose syrup, glycerin, partially hydrogenated cottonseed oil, soy lecithin, sucrose, water>

Questions

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

OTC Principal Display Panel

Enter section text here<USNDC 12546-108-20 and CA NDC 67238-108-20 Halls Warm Ups Butterscotch 20 drops bag>

HALLS  BUTTERSCOTCH
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-108
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol5 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
CARAMEL 
GLYCERIN 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colorbrown (LIGHT BROWN) Scoreno score
ShapeOVALSize22mm
FlavorBUTTERSCOTCH (BUTTERSCOTCH FLAVOR) Imprint CodeH
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-108-2020 LOZENGE (LOZENGE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2011
Labeler - Mondelez Global LLC (050964956)
Establishment
NameAddressID/FEIOperations
Mondelez Canada Inc246791201manufacture(12546-108)

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.

Hide
(web1)