THROAT RELIEF LOZENGES- benzocaine lozenge

Throat Relief Lozenges by

Drug Labeling and Warnings

Throat Relief Lozenges by is a Otc medication manufactured, distributed, or labeled by 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

Sore throat warning: severe or 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.

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 conatct 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.

OTHER SAFETY INFORMATION

Other information

store at room temperature

protect from moisture

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.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THROAT RELIEF LOZENGES 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-017
Route of Administration	ORAL

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

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

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	ROUND	Size	22mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-017-09	9 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/30/2012

Labeler - BestCo Inc. (002149136)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(52642-017)