HALLS STRAWBERRY- 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

<(per drop) Menthol 3.2 mg>

Purposes

<Cough suppressant, Oral anesthetic>

Uses

<temporarily relieves:>

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

Warnings

<Sore throat warning:  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 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

Enter section text here

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

• 15 calories per drop
• Contains:  SOY.

Inactive ingredients

<eucalyptus oil, FDC red 40, flavors, glucose syrup, 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: 12546-219-09 Halls Strawberry 9ct stick>

INGREDIENTS AND APPEARANCE

HALLS  STRAWBERRY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-219
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	3.2 mg

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (red)	Score	no score
Shape	capsule	Size	21mm
Flavor	STRAWBERRY (Strawberry)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-219-09	09 in 1 PACKAGE; Type 0: Not a Combination Product	06/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/16/2019

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc.		246791201	manufacture(12546-219)