cēpacol ®
08160ced-e19b-443e-ab16-0d3e4ae8a8ab
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Uses
Temporary relief of occasional
- sore throat
- sore mouth
- minor mouth irritation
- pain associated with canker sores
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
Other Information
- store between 20-25°C (68-77°F)
- protect contents from humidity
Inactive Ingredients
D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
Description
Drug Facts
Questions?
Call 1-866-682-4639
You may also report side effects to this phone number.
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 |
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.
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.
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
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
Other Information (Other information)
- store between 20-25°C (68-77°F)
- protect contents from humidity
Inactive Ingredients (Inactive ingredients)
D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
Questions?
Call 1-866-682-4639
You may also report side effects to this phone number.
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 |
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.
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.
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)
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:23.726512 · Updated: 2026-03-14T23:09:09.169888