HALLSSUGAR FREE EXTRA SUGAR FREE EXTRA STRONG MENTHOL- menthol lozenge

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

<(in each drop) 18 mg>

Purposes

<Oral Anesthetic>

Uses

<temporarily relieves occasional minor irritation and pain associated with

• sore throat
• sore mouth>

Warnings

<Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headached, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.>

Stop Use and Ask a Doctor if

• 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

• phenylketonurics:  contains phenylalanine 2 mg per drop
• excessive consumption may have a laxative effect
• 5 calories per drop
• contains: soy

Inactive ingredients

<acesulfame potassium, aspartame, citric acid, eucalyptus oil, FDC blue 1, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, 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 Sugar Free Extra Strong Menthol Flavor 9 drops package US NDC: 12546-314-09 and CA NDC: 67238-314-09>

INGREDIENTS AND APPEARANCE

HALLSSUGAR FREE EXTRA   SUGAR FREE EXTRA STRONG MENTHOL
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	18 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMALT (UNII: S870P55O2W)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (white with blue speckles)	Score	no score
Shape	SQUARE	Size	21mm
Flavor	MENTHOL (Sugar Free Extra Strong)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-314-09	09 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/04/2014

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc.		246791201	manufacture(12546-314)