Breezers Lozenge
FDA Label NDC 12546-151

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mondelez Global Llc for the product Breezers (NDC 12546-151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

<
  • 15 calories per drop
  • Contains: SOY.>

Inactive Ingredients

<citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, malic acid, potassium citrate, soy lecithin, sucrose, titanium dioxide, water>

Questions

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

Otc Principal Display Panel

<NDC 12546-151-30 Halls Breezers Cool Berry 30 ct Bag>

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