BREEZERS COOL BERRY- pectin lozenge

Breezers by

Drug Labeling and Warnings

Breezers 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) Pectin 7 mg>

Purpose

<Oral demulcent>

Uses

<temporarily relieves the following symptoms associated with sore mouth and sore throat:

• minor discomfort
• irritated areas>

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.>

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 or 2 drops (one at a time) slowly in the mouth.  Repeat as needed.
• children under 5 years, ask a doctor

Other information

<

• 15 calories per drop
• Contains: SOY.>

Inactive ingredients

<citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, 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

<NDC: 12546-151-25 Halls Breezers Cool Berry 25ct bag>   

INGREDIENTS AND APPEARANCE

BREEZERS  COOL BERRY
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pectin (UNII: 89NA02M4RX) (Pectin - UNII:89NA02M4RX)	Pectin	7 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (red with white stripe)	Score	no score
Shape	OVAL	Size	22mm
Flavor	BERRY (Cool Berry)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-151-25	25 in 1 BAG; Type 0: Not a Combination Product	03/24/2019
2	NDC: 12546-151-70	70 in 1 BAG; Type 0: Not a Combination Product	03/24/2019
3	NDC: 12546-151-30	30 in 1 BAG; Type 0: Not a Combination Product	03/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/24/2019

Labeler - Mondelez Global LLC (050964956)

Establishment
Name	Address	ID/FEI	Business Operations
Mondelez Canada Inc		246791201	manufacture(12546-151)