Medique sepasoothe lozenge

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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

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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

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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

Spl unclassified section

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.

Spl unclassified section

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 15-30C (59-86F)
  • 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

Ingredients and appearance - Product information

Medique sepasoothe lozenge- Hexylresorcinol, menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 47682-144
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Hexylresorcinol ( UNII: R9QTB5E82N)( Hexylresorcinol - UNII: R9QTB5E82N ) 2.4 mgin 1
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 4.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Corn syrup ( UNII: 9G5L16BK6N)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Methyl salicylate ( UNII: LAV5U5022Y)
Propylene glycol ( UNII: 6DC9Q167V3)
Sucrose ( UNII: C151H8M554)
Titanium dioxide ( UNII: 15FIX9V2JP)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Color green (green) Shape OVAL (OVAL)
Size 18 mm Score 1
Imprint Code N

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part356 USA

Labeler - Unifirst First Aid Corporation( 832947092)

Package label.principal display panel

909B Medique Sepasoothe Label

Medique ®

Sepasoothe

Pull to Open

Hexylresorcinol 2.4 mg

Menthol 4.5 mg

Anesthetic

24 Lozenges

(24 x 1)