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

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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

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

Other information

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 DrugM01312/28/2012
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc.002149136manufacture(0904-6255)

Revised: 11/2023
Document Id: 09bcb3ce-0646-291e-e063-6294a90aef73
Set id: 11416620-4892-44ba-9780-db27efff6743
Version: 3
Effective Time: 20231109
 
Major Pharmaceuticals