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Cepacol

Reckitt Benckiser LLC

Cēpacol ULTRA SORE THROAT SPRAY


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Benzocaine 5% Oral pain reliever
Glycerin 33% Oral demulcent

Cepacol Uses

for the temporary relief of

  • occasional minor irritation, pain, sore mouth, and sore throat
  • pain associated with canker sores
  • minor discomfort and protection of irritated areas in sore mouth and sore throat

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, swelling, 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

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.

Do not exceed recommended dosage.

Flammable. Keep away from fire, flame or heat.

When using this product

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
  • in rare cases, this product may cause a loss of sensation in the throat which is temporary and harmless
  • to avoid swallowing difficulties, avoid eating, chewing gum or sucking on lozenges for 20 minutes after using

Directions

  • adults and children 6 years of age and older: spray into throat or onto affected area with only ONE spray per use. Allow to remain in place for at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
  • children 6 to under 12 years of age should be supervised in the use of this product
  • children under 6 years of age: do not use

Cepacol Other information

  • tamper evident: product is sealed for your protection. Do not use if printed seal over nozzle is torn or missing.
  • shake well before use
  • store at room temperature 20-25°C (68-77°F)
  • do not freeze

Inactive ingredients

acesulfame potassium, deionized water, flavors, neotame, polyoxyl-40 hydrogenated castor oil, povidone K90, SD alcohol 38B

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 22.2 mL Bottle Carton

NDC 63824-780-75

Cēpacol ®
ULTRA

SORE THROAT SPRAY

Benzocaine 5% | Oral Pain Reliever
Glycerin 33%
| Oral Demulcent

Ultra1 SHOT for Pain Relief
Instant Acting • On-the-Go Comfort

100
Sprays

SUGAR FREE
cherry

0.75 FL OZ (22.2 mL)

Cepacol

Cepacol

Benzocaine and Glycerin SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-780
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 5 g
GLYCERIN 33 g

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
water
Neotame
POLYOXYL 40 HYDROGENATED CASTOR OIL
POVIDONE K90

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 22.2 in 1 BOTTLE
2 NDC:63824-780-75 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-05-03


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Be sure to consult your doctor before taking any medication!
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