Cepacol Lozenge
FDA Label NDC 63824-744

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

Other

Drug Facts

Do not exceed recommended dosage.

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

Otc - Purpose

Active ingredients (in each lozenge)Purposes
Benzocaine 7.5 mgOral pain reliever
Dextromethorphan hydrobromide 5 mgCough suppressant

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold
  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

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

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

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.

Otc - Ask Doctor

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)

Otc - Stop Use

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

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Directions

  • adults and children 12 years of age 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

  • store between 20-25°C (68-77°F)
  • protect contents from humidity

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, 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.

Principal Display Panel - 16 Lozenge Blister Pack Carton

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

  • Relieves Sore Throat Pain
  • Quiets Cough    • Fast Acting
  • Maximum Numbing
  • 16 Lozenges mixed berry

    *based on amount of benzocaine per adult dose.

    Principal Display Panel (16 Lozenge Blister Pack Carton)

    Principal Display Panel (16 Lozenge Blister Pack Carton)

* Please review the disclaimer below.