Cepacol Lozenge
FDA Label NDC 63824-713

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 63824-713). 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, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

    • Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224
    Made in England

Otc - Purpose

Active ingredients (in each lozenge)Purposes
Benzocaine 15 mgOral pain reliever
Menthol 3.6 mgOral pain reliever

Uses

Temporary relief of occasional

  • sore throat
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

Otc - Do Not Use

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.

Otc - Ask Doctor

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 - 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, rash, or fever develops

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.

Otc - When Using

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 between 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, 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 63824-713-16

READ ALL INFORMATION

Cēpacol®
EXTRA STRENGTH*

1 LOZENGE
EVERY 2
hours

#1
DOCTOR
RECOMMENDED†

SORE THROAT
Benzocaine 15 mg • Menthol 3.6 mg ∣ Oral Pain Reliever

• Relieves Sore Throat Pain
• Fast Acting
• Maximum Numbing

16 Lozenges cherry
*based on amount of benzocaine per dose.

Principal Display Panel (16 Lozenge Blister Pack Carton)

Principal Display Panel (16 Lozenge Blister Pack Carton)

* Please review the disclaimer below.