CHERRY SORE THROAT LOZENGES- benzocaine lozenge

Cherry Sore Throat Lozenges by

Drug Labeling and Warnings

Cherry Sore Throat Lozenges by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

PURPOSE

Purpose

Oral anesthetic

Oral anesthetic

INDICATIONS & USAGE

Uses temporarily relieves these symptoms:

occasional minor irritation, pain, sore mouth and sore throat

pain associated with canker sores

WARNINGS

Warnings

Sore throat warning: severe of persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or give to children under 5 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

STOP USE

Stop use and ask doctor if

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

sore mouth symptoms do not improve in 7 days

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

adults and children 5 years and older allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.

children under 5 years ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: corn starch*, FD&C Red 40, glucose syrup, glycerin*, medium chain triglycerides*, natural & artificial flavors, propylene glycol, soybean oil*, sucrose, and water. *May contain these ingredients.

QUESTIONS

Questions? Call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHERRY SORE THROAT LOZENGES 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-027
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.6 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	ROUND	Size	17mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-027-18	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/27/2016	01/01/2021

Labeler - DZA Brands LLC (090322194)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(55316-027)