Halls Breezers Sugar Free Cool Berry: Package Insert and Label Information

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.

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (PECTIN) PECTIN 7 mg

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM ASPARTAME ANHYDROUS CITRIC ACID FD&C BLUE NO. 2 FD&C RED NO. 40 ISOMALT MALIC ACID MALTITOL POTASSIUM CITRATE LECITHIN, SOYBEAN TITANIUM DIOXIDE WATER

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 Multilevel Packaging 1 NDC:12546-720-20 20 LOZENGE in 1 BAG None

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)

Establishment
Name	Address	ID/FEI	Operations
Mondelez Canada Inc		246791201	manufacture (12546-720)

Revised: 03/2023 Mondelez Global LLC