Berry Breezer Throat Drops: Package Insert and Label Information

BERRY BREEZER THROAT DROPS- pectin lozenge
CVS Pharmacy

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 (in each drop)

Pectin 7.0 mg

Purpose

Oral demulcent

Uses temporarily relieves:

occasional minor mouth irritation and sore throat

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. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have:

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessive phlegm (mucus)

Stop use and consult doctor if

cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

sore throat is severe, or irritation, pain or redness lasts or worsens

sore mouth does not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

adults and children 5 years and over — allow 1 drop to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 5 years — ask a doctor

Inactive ingredients: Artificial flavors, coconut oil, corn starch, FD&C red #40, glucose syrup, glycerin, malic acid, medium chain triglycerides, soybean oil, soy lecithin, sucrose, titanium dioxide, and water.

Questions? Or to report an adverse event call 1-800-245-2898, Monday — Friday, 9AM to 4PM EST

BERRY BREEZER THROAT DROPS pectin lozenge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-595 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 WATER

Product Characteristics Color red (red with white stripe) Score no score Shape OVAL Size 20mm Flavor BERRY Imprint Code B Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59779-595-25 25 LOZENGE in 1 BAG None

(click image for full-size original)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/18/2015

Labeler — CVS Pharmacy (062312574)

Registrant — Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Operations
Bestco Inc.		002149136	manufacture (59779-595)

Revised: 09/2016 CVS Pharmacy