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 Grandall Distributing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 2.6 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 produce may cause methemoglobinemia, a serious conditionthat must be treated promptly because it reduces the amount of oxygen 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, 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, or if irritation, pain, or redness persist 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.

Other Information

• store at room temperature
• protect from moisture
• Contains FD&C yellow no. 5 (tartrazine) as a color additive

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 2 hours as necessary or as directed by a doctor.

children under 5 years - do not use

INACTIVE INGREDIENT

Inactive ingredients: Corn starch, FD&C yellow no. 5 (tartrazine), glucose syrup, glycerin, honey, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose and water.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HONEY LEMON SORE THROAT LOZENGES 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-013
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: 48201-013-18	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/07/2018

Labeler - Grandall Distributing (044428324)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(48201-013)