Other
Drug Facts
Do not exceed recommended dosage.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
Cepacol Lozenge
FDA Label NDC 17856-0732
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Cepacol (NDC 17856-0732). 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, stop use and ask a doctor or dentist if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each lozenge) | Purposes |
|---|---|
| Benzocaine 15 mg | Oral pain reliever |
| Menthol 2.6 mg | Oral pain reliever |
Uses
Temporary relief of occasional
- 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.
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.
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 yellow no. 10, FD&C yellow no. 6, 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.
* Please review the disclaimer below.
