HALLS BUTTERSCOTCH- menthol lozenge

Halls by

Drug Labeling and Warnings

Halls by is a Otc medication manufactured, distributed, or labeled by Mondelez Global LLC, Mondelez Canada Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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>

INGREDIENTS AND APPEARANCE

HALLS  BUTTERSCOTCH
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	5 mg

Inactive Ingredients
Ingredient Name	Strength
BETA CAROTENE (UNII: 01YAE03M7J)
CARAMEL (UNII: T9D99G2B1R)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	brown (LIGHT BROWN)	Score	no score
Shape	OVAL	Size	22mm
Flavor	BUTTERSCOTCH (BUTTERSCOTCH FLAVOR)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-108-20	20 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2011

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc		246791201	manufacture(12546-108)