Cēpacol ®

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (15 mg) Menthol, Unspecified Form (3.6 mg)

Inactive Ingredients

D&c Red No. 33 Fd&c Red No. 40 Isomalt Maltitol Propylene Glycol Water Sodium Bicarbonate Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: S Shape: round Color: red Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-07-15 Until 2016-08-12

Medication Information

Description

Drug Facts

Uses

USES

temporarily relieves occasional minor irritation and pain associated with:

sore throat
sore mouth
canker sores

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 53414-9

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

Section 55105-1

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

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 years of age: do not use

Do Not Use

for teething
in children under 5 years of age

Questions?

1-866-682-4639

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.

Other Information

store at 20-25°C (68-77°F)
protect contents from humidity

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.

Inactive Ingredients

D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

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

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

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 Acting
Maximum Numbing*

16 Lozenges cherry flavor

*based on amount of benzocaine per dose

Structured Label Content

Uses

USES

temporarily relieves occasional minor irritation and pain associated with:

sore throat
sore mouth
canker sores

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

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 years of age: do not use

Do Not Use (Do not use)

for teething
in children under 5 years of age

Questions?

1-866-682-4639

Allergy Alert (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.

Other Information (Other information)

store at 20-25°C (68-77°F)
protect contents from humidity

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Methemoglobinemia Warning (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

Stop Use and Ask A Doctor Or Dentist If (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

Principal Display Panel 16 Lozenge Blister Pack Carton (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 Acting
Maximum Numbing*

16 Lozenges cherry flavor

*based on amount of benzocaine per dose

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "USES temporarily relieves occasional minor irritation and pain associated with: sore throat sore mouth canker sores", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each lozenge) Purposes Benzocaine 15 mg Oral pain reliever Menthol 3.6 mg Oral pain reliever", "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 years of age: do not use", "Do not use": "for teething in children under 5 years of age", "Questions?": "1-866-682-4639", "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.", "Other information": "store at 20-25°C (68-77°F) protect contents from humidity", "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.", "Inactive ingredients": "D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose", "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", "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", "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 Acting Maximum Numbing* 16 Lozenges cherry flavor *based on amount of benzocaine per dose"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information