DailyMed - CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

NDC Code(s): 63824-713-04, 63824-713-16, 63824-713-94
Packager: RB Health (US) LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 27, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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ACTIVE INGREDIENT
Active ingredients (in each lozenge)Purposes - Benzocaine 15 mgOral pain reliever - Menthol 3.6 mgOral pain reliever

Active ingredients (in each lozenge) Purposes

Benzocaine 15 mg Oral pain reliever

Menthol 3.6 mg Oral pain reliever

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Uses
USES - temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores
USES

temporarily relieves occasional minor irritation and pain associated with:
- sore throat
- sore mouth
- canker sores
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Warnings
Methemoglobinemia warning - Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can ...
Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
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

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Do not use
- for teething
- in children 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 out of reach of children.

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

Do not exceed recommended dosage.

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Directions
adults and children 5 years of age and older: allow one 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 ...
- adults and children 5 years of age and older: allow one 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
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Other information
store at 20-25°C (68-77°F) protect contents from humidity
- store at 20-25°C (68-77°F)
- protect contents from humidity
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Inactive ingredients
D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
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Questions?
1-866-682-4639

1-866-682-4639

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SPL UNCLASSIFIED SECTION
Dist. by: RB Health (US) Parsippany, NJ 07054-0224 - Made in England

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England
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PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
NDC 63824-713-16 - Cēpacol - ® EXTRA STRENGTH - #1 - DOCTOR - RECOMMENDED - † SORE THROAT - Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers - Relieves Sore Throat Pain - Fast ...
NDC 63824-713-16

Cēpacol ®
EXTRA STRENGTH

#1
DOCTOR
RECOMMENDED †

SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers
- Relieves Sore Throat Pain
- Fast Acting
- Maximum Numbing*
16 Lozenges cherry flavor
*based on amount of benzocaine per dose

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Active ingredients (in each lozenge)	Purposes
Benzocaine 15 mg	Oral pain reliever
Menthol 3.6 mg	Oral pain reliever

INGREDIENTS AND APPEARANCE

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Published Date (What is this?)	Version	Files
Mar 31, 2025	10 (current)	download
Apr 10, 2024	9	download
Jan 26, 2024	8	download
Oct 3, 2023	7	download
Jan 14, 2022	6	download
May 13, 2019	5	download
Jul 5, 2016	4	download
Apr 1, 2015	3	download
Sep 17, 2014	2	download
Oct 18, 2013	1	download

Published Date (What is this?)

Version

Files

Mar 31, 2025

10 (current)

download

Apr 10, 2024

download

Jan 26, 2024

download

Oct 3, 2023

download

Jan 14, 2022

download

May 13, 2019

download

Jul 5, 2016

download

Apr 1, 2015

download

Sep 17, 2014

download

Oct 18, 2013

download

	RxCUI	RxNorm NAME	RxTTY
1	824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	PSN
2	824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD
3	1235477	Cepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge	PSN
4	1235477	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD
5	1235477	Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge	SY
6	1235477	Cepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge	SY

Label: CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

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Drug Label Info

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Drug Label Information

Methemoglobinemia warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor or dentist if

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	63824-713-04
2	63824-713-16
3	63824-713-94

Label: CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Methemoglobinemia warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor or dentist if

Find additional resources

Safety

Related Resources

More Info on this Drug

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

Number of versions: 10

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

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CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

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