Indications and uses
temporarily relieves sore throat sore mouth minor mouth irritation pain associated with canker sores cough due to minor throat and bronchial irritation as may occur with the common cold
Cepacol
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2011-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:49:58
Label at a glance#
ProductCepacol SORE THROAT AND COUGH
Active ingredientBenzocaine, Dextromethorphan Hydrobromide
Label structure10 sections
Storage and handling
tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing. store at room temperature 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) | Purpose |
|---|---|
| Benzocaine 7.5 mg | Oral pain reliever |
| Dextromethorphan hydrobromide 5 mg | Cough suppressant |
Uses
temporarily relieves
- sore throat
- sore mouth
- minor mouth irritation
- pain associated with canker sores
- cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
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.
OTC - DO NOT USE SECTION
Do not use in a child under 6 years of age.
OTC - DO NOT USE SECTION
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that is accompanied by excessive phlegm (mucus)
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 develops
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness
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 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.
DOSAGE & ADMINISTRATION SECTION
Do not exceed recommended dosage.
Directions
- adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
- children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
- children under 6 years of age: do not use
Other information
- tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
- store at room temperature 20-25°C (68-77°F)
- protect contents from humidity
Inactive ingredients
acesulfame potassium, cetylpyridinium chloride, FD&C blue #1, FD&C red #40, flavors, glucose, propylene glycol, purified water, sodium bicarbonate, sucrose
Questions?
Call 1-888-963-3382
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
PRINCIPAL DISPLAY PANEL - 16 Lozenges Carton
NDC 63824-741-16
Cēpacol®
SORE THROAT & COUGH
Benzocaine 7.5 mg
Oral Pain Reliever
Dextromethorphan HBr 5 mg
Cough Suppressant
- Instant Acting
- Maximum Strength Numbing
16 Lozenges
mixed berry
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-741-16 | 2023-09-07 | C162847 | 48780-1 | 9d75b9d0-84f4-f424-e053-dadaa90a57ce | Cēpacol ® SORE THROAT AND COUGH |
| 63824-741-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-84f4-f424-e053-dadaa90a57ce | Cēpacol ® SORE THROAT AND COUGH |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 |
Products#
Every source-derived product name is available through these pages.
- Cepacol SORE THROAT AND COUGH
- Benzocaine and Dextromethorphan Hydrobromide
- Benzocaine
- Dextromethorphan Hydrobromide
- Dextromethorphan
- acesulfame potassium
- cetylpyridinium chloride
- FD&C blue no. 1
- FD&C red no. 40
- dextrose
- propylene glycol
- water
- sodium bicarbonate
- sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-741 | 63824-741-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| acesulfame potassium | 23OV73Q5G9 | IACT |
| cetylpyridinium chloride | D9OM4SK49P | IACT |
| FD&C blue no. 1 | H3R47K3TBD | IACT |
| FD&C red no. 40 | WZB9127XOA | IACT |
| dextrose | IY9XDZ35W2 | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| sodium bicarbonate | 8MDF5V39QO | IACT |
| sucrose | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| 017f7614-fff1-5264-e063-6294a90a382e | 66b43243-f29e-4e8c-925d-692d894de240 | 2023-07-27 | Warnings | 66b43243-f29e-4e8c-925d-692d894de240 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.