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
- 2013-10-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:39:24
Label at a glance#
ProductCepacol Extra Strength Sore Throat mixed berry
Active ingredientBENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
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, ...
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) | Purposes |
|---|---|
| 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.
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 occurs with too much 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.
SPL UNCLASSIFIED 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, 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
Made in England
PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton
NDC 63824-743-16
Cēpacol®
EXTRA STRENGTH*
TAKE
EVERY
4
hours
SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant
- Relieves Sore Throat Pain
- Fast Acting
- Maximum Numbing
16
Lozenges
mixed berry
*based on amount of benzocaine per adult dose.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-743-16 | 2023-09-07 | C162847 | 48780-1 | 9d75b9d0-2aaf-f424-e053-dadaa90a57ce | Cēpacol ® Extra Strength* Sore Throat mixed berry |
| 63824-743-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2aaf-f424-e053-dadaa90a57ce | Cēpacol ® Extra Strength* Sore Throat mixed berry |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-743-16 | EA - Each | 63824-743 | cec5a9bf-68b4-474d-86c8-7d41212a6441 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 2 | |
| dextrose | INACTIVE INGREDIENT | IY9XDZ35W2 | 2 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | 2 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Cepacol Extra Strength Sore Throat mixed berry
- BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
- BENZOCAINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- acesulfame potassium
- FD&C Blue No. 1
- FD&C Red No. 40
- dextrose
- propylene glycol
- water
- sodium bicarbonate
- sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-743 | 63824-743-16 |
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 |
| 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#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| dextrose | DEXTROSE | IY9XDZ35W2 | TABLET, EXTENDED RELEASE / ORAL | 103.95 mg | ||
| dextrose | DEXTROSE | IY9XDZ35W2 | TABLET, DELAYED RELEASE / ORAL | NA | ||
| dextrose | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRAVENOUS | 51.7 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | LOZENGE / ORAL | 100 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / SUBLINGUAL | 6 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | ADJ PH | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 4 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FOR SUSPENSION / ORAL | 80 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET / ORAL | 111 mg | ||
| dextrose | DEXTROSE | IY9XDZ35W2 | SYRUP / ORAL | 620 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | FILM / SUBLINGUAL | 5 mg | ||
| dextrose | DEXTROSE | IY9XDZ35W2 | TABLET, COATED / ORAL | 132 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | POWDER, FOR SOLUTION / ORAL | 1250 mg/100ml |
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 |
|---|---|---|---|---|---|---|
| 017f6c39-3df4-57d4-e063-6294a90a290e | d25f736d-07ee-40cf-bc16-0f2c231eecd1 | 2023-07-27 | Warnings | d25f736d-07ee-40cf-bc16-0f2c231eecd1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.