MEDIQUE SEPASOOTHE - hexylresorcinol and menthol lozenge 
Unifirst First Aid Corporation

----------

HEXYLRESORCINOL, MENTHOL

Drug Facts

Active ingredient (in each lozenge)

Hexylresorcinol 2.4mg

Menthol 4.5mg

Purpose

Oral anesthetic

Oral anesthetic

Uses

Temporarily relieves these symptoms

• occasional minor irritation
• pain
• sore mouth
• sore throat

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 doctor right away. Do not use more than 2 days or give to children under 12 years of age.

Stop using this product and ask a doctor if

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

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

Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed

Adults and children: (12 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 12 years: Do not give to children under 12 years of age.

Other information

• read all warnings and directions before use.
• TAMPER EVIDENT: Do not use if packet is torn, ripped or shows any signs of tampering.
• store at room temperature 15º-30ºC (59º-86ºF)
• protect from moisture

Inactive ingredients

corn syrup, D&C yellow no. 10, FD&C blue no. 1, methyl salicylate, propylene glycol, sucrose, titanium dioxide, water

Questions or comments? Call 1-800-634-7680

909B Medique Sepasoothe Label

Medique®

Sepasoothe

Pull to Open

Hexylresorcinol 2.4 mg

Menthol 4.5 mg

Anesthetic

24 Lozenges

(24 x 1)

MEDIQUE SEPASOOTHE  hexylresorcinol, menthol   lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 47682-144 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEXYLRESORCINOL (HEXYLRESORCINOL) HEXYLRESORCINOL 2.4 mg MENTHOL (MENTHOL) MENTHOL 4.5 mg

Inactive Ingredients Ingredient Name Strength CORN SYRUP   D&C YELLOW NO. 10   FD&C BLUE NO. 1   METHYL SALICYLATE   PROPYLENE GLYCOL   SUCROSE   TITANIUM DIOXIDE   WATER

Product Characteristics Color green (green) Score no score Shape OVAL (OVAL) Size 18mm Flavor Imprint Code N Contains

Packaging # NDC Package Description Multilevel Packaging 1 47682-144-13 500 CELLO PACK In 1 BOX, UNIT-DOSE contains a CELLO PACK 1 1 LOZENGE In 1 CELLO PACK This package is contained within the BOX, UNIT-DOSE (47682-144-13) 2 47682-144-48 250 CELLO PACK In 1 BOX, UNIT-DOSE contains a CELLO PACK 2 1 LOZENGE In 1 CELLO PACK This package is contained within the BOX, UNIT-DOSE (47682-144-48) 3 47682-144-33 100 CELLO PACK In 1 BOX, UNIT-DOSE contains a CELLO PACK 3 1 LOZENGE In 1 CELLO PACK This package is contained within the BOX, UNIT-DOSE (47682-144-33) 4 47682-144-64 24 CELLO PACK In 1 BOX, UNIT-DOSE contains a CELLO PACK 4 1 LOZENGE In 1 CELLO PACK This package is contained within the BOX, UNIT-DOSE (47682-144-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/08/2011

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 03/2011Unifirst First Aid Corporation