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
HALLS
BREEZERS SUGAR FREE COOL BERRY pectin lozenge | ||||||||||||||||||||||||||||
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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.
https://otclabels.com/lib/otc/otc-meds/halls-breezers-sugar-free-cool-berry/