SORE THROAT LOGENZES SORE THROAT- benzocaine and menthol lozenge 
Major Pharmaceuticals

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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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

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

front1drugfacts1

SORE THROAT LOGENZES  SORE THROAT
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6255-4918 in 1 CARTON12/28/2012
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2012
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc.002149136manufacture(0904-6255)

Revised: 10/2019
Document Id: 951c6eb7-7ddc-2fc9-e053-2995a90a9f65
Set id: 11416620-4892-44ba-9780-db27efff6743
Version: 2
Effective Time: 20191017
 
Major Pharmaceuticals