Sore Throat Lozenges

Drug Labeling and Warnings

Drug Details [pdf]

SORE THROAT RELIEF CHERRY FLAVOR- benzocaine and menthol lozenge 
Safecor Health, LLC
Reference Label Set Id: 118b103b-3680-42d5-abfa-5474cf0acd8f

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sore Throat Lozenges

Sore Throat Lozenges Cherry Flavored

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

Uses

temporarily relieves these symptoms:

• occasional minor irritation, pain, sore mouth and sore throat
• 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:

Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

Stop Use and ask a doctor if

• sore throat is severe or irritation, pain or redness persists or worsens
• sore mouth symptom do not improve in 7 days

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.

Directions

•   adults and children 5 years and older: allow 1 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: ask a doctor

Other information

• store at room temperature
• protect from moisture

Inactive ingredients

FD&C Red 40, glucose syrup, natural and artificial flavoring, propylene glycol, sucrose, and water. Soybean oil and corn starch used as processing aids.

Questions or comments?

Call 1-800-447-1006

Packaged and Distributed by:

Safecor Health, LLC

317 New Boston Street, Suite 100

Woburn, MA 01801

Sore Throat Lozenges Cherry Flavored 100 Unit Dose Lozenges (48433-111-01)

Safecor Health

Sore Throat Lozenges

BENZOCAINE 15 mg/MENTHOL 3.6 mg

Cherry Flavored

Compare to active ingredients in Cepacol*

This package is not child resistant. For institutional use only.

This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered

trademark Cepacol®.

Questions or Comments? Call 1-800-447-1006.

100 UNIT DOSE LOZENGES

SORE THROAT RELIEF CHERRY FLAVOR 
benzocaine, menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-111(NDC: 52642-010)
Route of Administration	ORAL	DEA Schedule

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)
CORN SYRUP (UNII: 9G5L16BK6N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	19mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-111-01	100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	08/25/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/25/2014

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	REPACK(48433-111)

Revised: 6/2014

Document Id: 33c8c8f4-faaa-4bda-90c1-56e29c89b516

Set id: 33c8c8f4-faaa-4bda-90c1-56e29c89b516

Version: 1

Effective Time: 20140604