Cēpacol

Cēpacol
SPL v2
SPL
SPL Set ID 71a80e13-bda3-40fb-b4e7-45e9985e707c
Route
ORAL
Published
Effective Date 2024-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg) Menthol (3.6 mg)
Inactive Ingredients
Fd&c Red No. 40 Propylene Glycol Water Corn Syrup Allyl Sucrose Hydrogenated Soybean Oil

Identifiers & Packaging

Pill Appearance
Shape: round Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-12-28

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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
Section 50567-7

Do not exceed recommended dosage.

Section 50570-1

Do not usein a child under 5 years of age.

Section 53414-9

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

Section 55105-1
Active ingredients (in each lozenge) Purpose
 Benzocaine 15 mg  Oral pain reliever
 Menthol 3.6 mg  Oral pain reliever
Directions
  • 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: ask a doctor
Questions?

Call 1-800-616-2471

Allergy Alert
  • 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.
Principal Panel

Other Information
  • tamper evident packaging: Do not use if outer box or blister is open or damaged. 
  • store at room temperature
  • protect contents from moisture
Sore Throat Warning
  • 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.
Inactive Ingredients

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.


Structured Label Content

Uses

temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

Do not exceed recommended dosage.

Section 50570-1 (50570-1)

Do not usein a child under 5 years of age.

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) Purpose
 Benzocaine 15 mg  Oral pain reliever
 Menthol 3.6 mg  Oral pain reliever
Directions
  • 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: ask a doctor
Questions?

Call 1-800-616-2471

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 any other 'caine' anesthetics.
Principal Panel (PRINCIPAL PANEL)

Other Information (Other information)
  • tamper evident packaging: Do not use if outer box or blister is open or damaged. 
  • store at room temperature
  • protect contents from moisture
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, nausea or vomiting consult a doctor promptly.
Inactive Ingredients (Inactive ingredients)

Glucose syrup, N&A flavoring, propylene glycol, red #40, sucrose, and water. Soybean oil used as processing aid.


Advanced Ingredient Data


Raw Label Data

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