Cepacol

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each lozenge)	Purpose
Benzocaine 15 mg	Oral pain reliever
Menthol 2.6 mg	Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporary relief of occasional

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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.

OTC - DO NOT USE SECTION

Do not use in a child under 5 years of age.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - WHEN USING SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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: do not use

Other information

STORAGE AND HANDLING SECTION

• tamper evident: product is sealed in blister package for your protection. Do not use if carton or blister package has been disturbed or opened.
• store at room temperature 20-25°C (68-77°F)
• protect contents from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetylpyridinium chloride, D&C yellow #10, FD&C yellow #6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-888-963-3382

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-730-16

NEW PACK, SAME RELIEF!

Cēpacol^®

SORE THROAT

Benzocaine 15 mg | Menthol 2.6 mg
Oral Pain Reliever

• Instant Acting
• Maximum Strength Numbing

16 Lozenges

honey lemon

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Cepacol Sore Throat
• Benzocaine and Menthol
• Benzocaine
• Menthol
• cetylpyridinium chloride
• D&C yellow no. 10
• FD&C yellow no. 6
• isomalt
• maltitol
• propylene glycol
• water
• sodium bicarbonate
• sucralose

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

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