Cēpacol ®

Cēpacol ®
SPL v9
SPL
SPL Set ID d771095b-7de3-48f3-a125-8bc76e7d1778
Route
ORAL
Published
Effective Date 2022-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg) Menthol, Unspecified Form (2.6 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Yellow No. 6 Isomalt Maltitol Propylene Glycol Water Sodium Bicarbonate Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: s Shape: round Color: orange Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-15

Description

Drug Facts


Medication Information

Indications and Usage

Uses:

temporarily relieves occasional minor irritation and pain associated with:

  • sore throat
  • sore mouth
  • canker sores
Dosage and Administration
  • 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
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.

Do not exceed recommended dosage.

Section 50566-9
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
Section 50570-1
  • for teething
  • in children under 5 years of age
Section 51727-6

D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Section 51945-4

NDC 63824-732-16

Cēpacol ®

EXTRA STRENGTH

#1

DOCTOR

RECOMMENDED

SORE THROAT

Benzocaine 15 mg • Menthol 2.6 mg | Oral Pain Relievers

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

16 Lozenges honey lemon flavor

*based on amount of benzocaine per 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 15 mg Oral pain reliever
Menthol 2.6 mg Oral pain reliever

Structured Label Content

Indications and Usage (34067-9)

Uses:

temporarily relieves occasional minor irritation and pain associated with:

  • sore throat
  • sore mouth
  • canker sores
Dosage and Administration (34068-7)
  • 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
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.

Do not exceed recommended dosage.

Section 50566-9 (50566-9)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops
Section 50570-1 (50570-1)
  • for teething
  • in children under 5 years of age
Section 51727-6 (51727-6)

D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Section 51945-4 (51945-4)

NDC 63824-732-16

Cēpacol ®

EXTRA STRENGTH

#1

DOCTOR

RECOMMENDED

SORE THROAT

Benzocaine 15 mg • Menthol 2.6 mg | Oral Pain Relievers

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

16 Lozenges honey lemon flavor

*based on amount of benzocaine per 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 15 mg Oral pain reliever
Menthol 2.6 mg Oral pain reliever

Advanced Ingredient Data


Raw Label Data

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