HONEY LEMON SORE THROAT LOZENGES- benzocaine lozenge

Honey Lemon Sore Throat Lozenges by

Drug Labeling and Warnings

Honey Lemon Sore Throat Lozenges by is a Otc medication manufactured, distributed, or labeled by TopCo, Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each drop)

Benzocaine 15.0 mg

Menthol 2.6 mg

PURPOSE

Purposes

Oral anesthetic

Oral anesthetic

INDICATIONS & USAGE

Uses

Temporarily relieves the following symptoms:

occasional minor irritation, pain, sore mouth and sore throat

WARNINGS

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that is accompanied by 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.

DO NOT USE

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 consult 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 a 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 2 hours as necessary or as directed by a dentist or 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 yellow #5 (tartrazine), glucose syrup, glycerin, honey, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose, and water.

QUESTIONS

Questions? Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HONEY LEMON SORE THROAT LOZENGES 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-833
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg

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

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	17mm
Flavor	HONEY (Honey and Lemon)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-833-18	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/21/2017	11/01/2020

Labeler - TopCo (006935977)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(36800-833)