HALLS BREEZERS SUGAR FREE COOL BERRY- pectin 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) 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

• phenylketonurics: contains phenylalanine 2 mg per drop
• excessive consumption may have a laxative effect
• 10 calories per drop
• Contains: SOY.

Inactive ingredients

acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, water

Questions

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

OTC Principal Display Panel

<NDC: 12546-720-20 Halls Breezers SF Cool Berry 20ct bag>

INGREDIENTS AND APPEARANCE

HALLS  BREEZERS SUGAR FREE COOL BERRY
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12546-720
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ISOMALT (UNII: S870P55O2W)
MALIC ACID (UNII: 817L1N4CKP)
MALTITOL (UNII: D65DG142WK)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red (red and white)	Score	no score
Shape	OVAL	Size	21mm
Flavor	BERRY (Cool Berry)	Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12546-720-20	20 in 1 BAG; Type 0: Not a Combination Product	05/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/27/2019

Labeler - Mondelez Global LLC (050964956)