SORE THROAT LOGENZES SORE THROAT- benzocaine and menthol lozenge

Sore Throat Logenzes by

Drug Labeling and Warnings

Sore Throat Logenzes by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Bestco, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purpose
Benzocaine 15 mg	Oral pain reliever
Menthol 3.6 mg	Oral pain reliever

Uses

temporary relief of occasional

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Warnings

Allergy alert

• Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning

• If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Do not use in a child under 5 years of age.

Stop use and ask a doctor or dentist if

• sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persists or worsens
• swelling, rash or fever develops

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

Keep this and all drugs out of the reach of children.

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

Do not exceed recommended dosage.

Directions

• adults and children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• children under 5 years of age: ask a doctor

Other information

• tamper evident packaging: Do not use if outer box or blister is open or damaged. 
• store at room temperature
• protect contents from moisture

Inactive ingredients

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.

Questions?

Call 1-800-616-2471

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Dist. by:
Major Pharmaceuticals
Livonia, MI 48150  USA

PRINCIPAL DISPLAY PANEL- 16 Lozenge Carton

NDC: 0904-6255-49

MAJOR SORE THROAT LOZENGES

Fast, Long Lasting Relief

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

18 Lozenges

cherry

INGREDIENTS AND APPEARANCE

SORE THROAT LOGENZES  SORE THROAT
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6255
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CORN SYRUP (UNII: 9G5L16BK6N)
ALLYL SUCROSE (UNII: VI3D59RW0U)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6255-49	18 in 1 CARTON	12/28/2012
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/28/2012

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc.		002149136	manufacture(0904-6255)