HALLS BREEZERS SUGAR FREE COOL BERRY- pectin lozenge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Pectin (UNII: 89NA02M4RX) (Pectin - UNII:89NA02M4RX)
Available from:
Mondelez Global LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- sore mouth does not improve in 7 days - irritation, pain, or redness persists or worsens
Authorization status:
OTC monograph not final
Authorization number:
12546-720-20

HALLS BREEZERS SUGAR FREE COOL BERRY- pectin lozenge

Mondelez Global LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredient

(per drop) Pectin 7 mg

Purpos e

<Oral Demulcent>

Us es

<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

Ques tions

<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>

HALLS BREEZERS SUGAR FREE COOL BERRY

pectin lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:12546 -720

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Pectin (UNII: 8 9 NA0 2M4RX) (Pectin - UNII:8 9 NA0 2M4RX)

Pe c tin

7 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ASPARTAME (UNII: Z0 H242BBR1)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ISO MALT (UNII: S8 70 P55O2W)

MALIC ACID (UNII: 8 17L1N4CKP)

MALTITO L (UNII: D6 5DG142WK)

PO TASSIUM CITRATE (UNII: EE9 0 ONI6 FF)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

red (red and white)

S core

no sco re

S hap e

OVAL

S iz e

21mm

Flavor

BERRY (Co o l Berry)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:12546 -720 -20

20 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 5/27/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 5/27/20 19

Mondelez Global LLC

Labeler -

Mondelez Global LLC (050964956)

Revised: 5/2019

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