FDA.reportPublic FDA data

CEPASTAT

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:33:58

Label at a glance#

ProductCEPASTAT Sore throat and Cough
Active ingredientMENTHOL, BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections

Indications and uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth cough due to minor throat and bronchial irritation as may occur with the common cold

Dosage and administration

Adults and children over 12 years of age:  2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours. Children 6-12 years of age:  1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours. Children under 6 years of age:  consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if blister package with “CĒPASTAT®” name has been disturbed or opened.

Drug Facts

Active Ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 6 mg

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic/Analgesic

Active Ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg 

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Active Ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Menthol 10 mg 

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic/Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves

  • occasional minor irritation, pain, sore throat and sore mouth
  • cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if

OTC - ASK DOCTOR SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.
  • Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.
  • Children under 6 years of age: consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • Store between 59ºF and 86ºF (15ºC - 30ºC).
  • Protect from moisture.
  • Check expiration date before using.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-552-7932 

PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045532benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG Oral LozengePSN3
1872897CEPASTAT Sore Throat & Cough 6 MG / 5 MG / 10 MG Oral LozengePSN3
1872897benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral Lozenge [Cepastat Sore Throat & Cough]SBD3
1045532benzocaine 6 MG / dextromethorphan hydrobromide 5 MG / menthol 10 MG Oral LozengeSCD3
1872897Cepastat Sore Throat & Cough (benzocaine 6 MG / dextromethorphan HBr 5 MG / menthol 10 MG) Oral LozengeSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-205-01CEPASTATSore throat and Cough6 in 1 BLISTER PACKLOZENGE63
63736-205-01CEPASTATSore throat and Cough3 in 1 CARTONLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-205CEPASTAT SORE THROAT AND COUGH (BENZOCAINE, DEXTROMETHORPHAN HBR, MENTHOL) LOZENGE [INSIGHT PHARMACEUTICALS LLC]3Legacy NDC, 2 package rows20241105_93f0e60f-4dda-4ec9-b391-e059a0876654.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-20563736-205-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
BENZOCAINEU3RSY48JW5ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
ISOMALTS870P55O2WIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5aaf0faf-b486-589b-e063-6394a90a121d93f0e60f-4dda-4ec9-b391-e059a08766542026-09-04WarningsExact identifier
spl set id: 93f0e60f-4dda-4ec9-b391-e059a0876654

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.