CHERRY SORE THROAT LOZENZE- benzocaine lozenge

cherry sore throat lozenze by

Drug Labeling and Warnings

cherry sore throat lozenze by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, 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

WARNINGS

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Sore throat warning: If sore throat is severe, persist 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, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

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.

DO NOT USE

Do not use

• for teething
• in children under 2 years of age

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 - do not use

INACTIVE INGREDIENT

Inactive ingredients: Corn starch, FD&C red no. 40, glucose syrup, glycerin, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

QUESTIONS

Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9am to 4pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHERRY SORE THROAT LOZENZE 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75981-008
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	no score
Shape	ROUND	Size	17mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75981-008-18	18 in 1 CARTON; Type 0: Not a Combination Product	03/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/29/2016

Labeler - Geiss, Destin & Dunn (076059836)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(75981-008)