Indications and uses
For the temporary relief of occasional sore throat sore mouth minor irritation pain pain associated with canker sores
Cepacol Extra Strength Sore Throat Cherry
- Manufacturer
- RB Health (US) LLC
- Effective date
- 2022-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:13:15
Label at a glance#
ProductCepacol Extra Strength Sore Throat Cherry
Active ingredientBenzocaine, Menthol, Unspecified Form
Label structure10 sections
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
Storage and handling
store at 20-25°C (68-77°F) protect contents from humidity
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each lozenge) | Purposes |
|---|---|
| Benzocaine 15 mg | Oral pain reliever |
| Menthol 3.6 mg | Oral pain reliever |
Uses
For the temporary relief of occasional
- sore throat
- sore mouth
- minor irritation
- pain
- pain associated with canker sores
Warnings
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. 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
Allergy alert
Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or 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, swelling, nausea, or vomiting, consult a doctor promptly.
Do not use
- for teething
- in children under 5 years of age
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - WHEN USING SECTION
Do not exceed recommended dosage.
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 at 20-25°C (68-77°F)
- protect contents from humidity
Inactive ingredients
D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, purified water, sodium bicarbonate, sucralose
Questions?
1-866-682-4639
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in India
PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
NDC 63824-715-16
READ ALL WARNINGS
Cēpacol®
EXTRA STRENGTH
#1
DOCTOR
RECOMMENDED†
SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg | Oral Pain Relievers
- Relieves Sore Throat Pain
- Fast Acting
- Maximum Numbing*
16 Lozenges cherry
*based on amount of benzocaine per dose
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-715-16 | EA - Each | 63824-715 | 3645af74-0aed-4309-b7e1-0efe5a7f4aaf | 1 | 2019-08-06 |
Products#
Every source-derived product name is available through these pages.
- Cepacol Extra Strength Sore Throat Cherry
- Benzocaine and Menthol, Unspecified Form
- Benzocaine
- Menthol, Unspecified Form
- D&C RED NO. 33
- FD&C RED NO. 40
- ISOMALT
- MALTITOL
- WATER
- SODIUM BICARBONATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-715 | 63824-715-16, 63824-715-36 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Menthol, Unspecified Form | L7T10EIP3A | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ISOMALT | S870P55O2W | IACT |
| MALTITOL | D65DG142WK | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4cc1750b-27cf-b83e-e063-6294a90ae51c | 94165dc9-ea46-4ab9-bdec-674e072b5ad5 | 2026-03-11 | Warnings | 94165dc9-ea46-4ab9-bdec-674e072b5ad5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.