Cēpacol ®

Cēpacol ®
SPL v7
SPL
SPL Set ID 08160ced-e19b-443e-ab16-0d3e4ae8a8ab
Route
ORAL
Published
Effective Date 2022-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (15 mg) Menthol (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

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 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
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
Questions?

Call 1-866-682-4639

You may also report side effects to this phone number.

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.
Other Information
  • store between 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, nausea, or vomiting, consult a doctor promptly.
Inactive Ingredients

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

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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
Cepacol Extra Strength Sore Throat Honey Lemon (benzocaine and Menthol) Lozenge


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 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
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
Questions?

Call 1-866-682-4639

You may also report side effects to this phone number.

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.
Other Information (Other information)
  • store between 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, nausea, or vomiting, consult a doctor promptly.
Inactive Ingredients (Inactive ingredients)

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

Methemoglobinemia Warning (METHEMOGLOBINEMIA WARNING)

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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
Cepacol Extra Strength Sore Throat Honey Lemon (benzocaine and Menthol) Lozenge (CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE)


Advanced Ingredient Data


Raw Label Data

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