FDA Label for Breezers Cool Berry
View Indications, Usage & Precautions
Breezers Cool Berry Product Label
The following document was submitted to the FDA by the labeler of this product Mondelez Global Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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