Other
Drug Facts
Do not exceed recommended dosage.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Cepacol (NDC 63824-744). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, methemoglobinemia warning, allergy alert, sore throat warning, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Do not exceed recommended dosage.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
| Active ingredients (in each lozenge) | Purposes |
|---|---|
| Benzocaine 7.5 mg | Oral pain reliever |
| Dextromethorphan hydrobromide 5 mg | Cough suppressant |
temporarily relieves
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:
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.
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.
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
Stop use and ask a doctor or dentist if
If pregnant or breast-feeding, ask a health professional before use.
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.
FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
Call 1-866-682-4639
You may also report side effects to this phone number.
NDC 63824-744-16
READ ALL INFORMATION
TAKE
EVERY
4
hours
Cēpacol®
EXTRA STRENGTH*
#1
DOCTOR
RECOMMENDED†
SORE THROAT & COUGH
Benzocaine 7.5 mg Oral Pain Reliever | Dextromethorphan HBr 5 mg Cough Suppressant
16 Lozenges mixed berry
*based on amount of benzocaine per adult dose.
* Please review the disclaimer below.