SORE THROAT LOGENZES SORE THROAT- benzocaine and menthol lozenge 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Cēpacol ®



SORE THROAT

Drug Facts

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Sore Throat LogenzesSore Throat Sore Throat

GENERIC: Benzocaine and Menthol

DOSAGE: LOZENGE

ADMINSTRATION: ORAL

NDC: 70518-3262-0

COLOR: red

FLAVOR: CHERRY

SHAPE: ROUND

SCORE: No score

SIZE: 18 mm

PACKAGING: 18 in 1 BLISTER PACK

OUTER PACKAGING: 18 in 1 CARTON

ACTIVE INGREDIENT(S):

  • MENTHOL 3.6mg in 1
  • BENZOCAINE 15mg in 1

INACTIVE INGREDIENT(S):

  • FD&C RED NO. 40
  • PROPYLENE GLYCOL
  • WATER
  • CORN SYRUP
  • ALLYL SUCROSE
  • HYDROGENATED SOYBEAN OIL

MM1

SORE THROAT LOGENZES  SORE THROAT
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3262(NDC:0904-6255)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3262-018 in 1 CARTON11/02/202110/16/2023
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/02/202110/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d7e496-5bdc-99d1-e063-6294a90a9db5
Set id: 5115bd75-96ca-4888-b06d-94bcd885a90e
Version: 5
Effective Time: 20231016
 
REMEDYREPACK INC.