CEPASTAT SORE THROAT AND COUGH- benzocaine, dextromethorphan hbr, menthol lozenge 
Insight Pharmaceuticals LLC

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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Cepastat Sore Throat and Cough

Tamper Evident: Do not use if blister package withCĒPASTAT®name has been disturbed or opened.

Drug Facts

Active Ingredients (in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients (in each lozenge)

Dextromethorphan HBr 5 mg 

Purpose

Cough Suppressant

Active Ingredients (in each lozenge)

Menthol 10 mg 

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.

Do not use

  • this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product. 
  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

When using this product

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
  • cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

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

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water

Questions?

1-800-552-7932 

PRINCIPAL DISPLAY PANEL

CĒPASTAT® 
SORE THROAT & COUGH
Menthol/Benzocaine | Oral Anesthetic/Analgesic
Dextromethorphan HBr 5 mg | Cough Suppressant
FAST ACTING
SORE THROAT & COUGH RELIEF

18 LOZENGES
CHERRY
SUGAR FREE

PRINCIPAL DISPLAY PANEL
CĒPASTAT® 
SORE THROAT & COUGH 
Menthol/Benzocaine | Oral Anesthetic/Analgesic
Dextromethorphan HBr 5 mg | Cough Suppressant
FAST ACTING
SORE THROAT & COUGH RELIEF

18 LOZENGES 
CHERRY
SUGAR FREE

CEPASTAT  SORE THROAT AND COUGH
benzocaine, dextromethorphan hbr, menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-205
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
ISOMALT (UNII: S870P55O2W)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize4mm
FlavorCHERRYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-205-013 in 1 CARTON10/01/2016
16 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 FINALpart35610/01/2016
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 3/2017
Document Id: c763b32e-91b7-4c97-baf5-f523f385a96e
Set id: 93f0e60f-4dda-4ec9-b391-e059a0876654
Version: 2
Effective Time: 20170310
 
Insight Pharmaceuticals LLC