Cēpacol ®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Benzocaine (7.5 mg)

Inactive Ingredients

Fd&c Blue No. 1 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 2014-05-05 Until 2024-04-14

Medication Information

Indications and Usage

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold
pain associated with canker sores
occasional irritation and pain due to a sore mouth or sore throat

Dosage and Administration

adults and children 12 years of age and older	take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist
children 6 to under 12 years of age	take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist
children under 6 years of age	do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

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

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 50566-9

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling develops
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Section 50570-1

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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
for teething
in children under 6 years of age

Section 51727-6

FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose

Section 51945-4

NDC 63824-744-16

Cēpacol _®

EXTRA STRENGTH

#1

DOCTOR

RECOMMENDED ^†

SORE THROAT & COUGH

Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

Relieves Sore Throat Pain
Quiets Cough • Fast Acting
Maximum Numbing*

16 Lozenges mixed berry flavor

*based on amount of benzocaine per adult dose

Section 53413-1

1-866-682-4639

Section 53414-9

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

Section 55105-1

Active ingredients (in each lozenge)	Purposes
Benzocaine 7.5 mg	Oral pain reliever
Dextromethorphan HBr 5 mg	Cough suppressant

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold
pain associated with canker sores
occasional irritation and pain due to a sore mouth or sore throat

Dosage and Administration (34068-7)

adults and children 12 years of age and older	take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist
children 6 to under 12 years of age	take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist
children under 6 years of age	do not use

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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

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 50566-9 (50566-9)

sore mouth symptoms do not improve in 7 days
irritation, pain, or redness persists or worsens
swelling develops
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

persistent or chronic cough such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Section 50570-1 (50570-1)

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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
for teething
in children under 6 years of age

Section 51727-6 (51727-6)

FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose

Section 51945-4 (51945-4)

NDC 63824-744-16

Cēpacol _®

EXTRA STRENGTH

#1

DOCTOR

RECOMMENDED ^†

SORE THROAT & COUGH

Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant

Relieves Sore Throat Pain
Quiets Cough • Fast Acting
Maximum Numbing*

16 Lozenges mixed berry flavor

*based on amount of benzocaine per adult dose

Section 53413-1 (53413-1)

1-866-682-4639

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 7.5 mg	Oral pain reliever
Dextromethorphan HBr 5 mg	Cough suppressant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat", "34068-7": "adults and children 12 years of age and older take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist children 6 to under 12 years of age take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist children under 6 years of age do not use", "42229-5": "Drug Facts", "44425-7": "store at 20-25°C (68-77°F) protect contents from humidity", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.", "50569-3": "persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)", "50570-1": "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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. for teething in children under 6 years of age", "51727-6": "FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, purified water, sucralose", "51945-4": "NDC 63824-744-16 Cēpacol ® EXTRA STRENGTH #1 DOCTOR RECOMMENDED † SORE THROAT & COUGH Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant Relieves Sore Throat Pain Quiets Cough • Fast Acting Maximum Numbing* 16 Lozenges mixed berry flavor *based on amount of benzocaine per adult dose", "53413-1": "1-866-682-4639", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information