OTC Medication Information: Halls Breezers Sugar Free Cool Berry

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

<NDC 12546-720-20 Halls SF Cool Berry 20ct bag>
(click image for full-size original)

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

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.