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Cepacol

Reckitt Benckiser LLC

Cēpacol SORE THROAT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each lozenge) Purpose
Benzocaine 15 mg Oral pain reliever
Menthol 3.6 mg Oral pain reliever

Cepacol Uses

temporary relief of occasional

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

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, nausea or vomiting consult a doctor promptly.

Do not use in a child under 5 years of age.

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

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.

Directions

  • adults and children 5 years or older: allow 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

Cepacol Other information

  • tamper evident: product is sealed in blister package for your protection. Do not use if carton or blister package has been disturbed or opened.
  • store at room temperature 20-25°C (68-77°F)
  • protect contents from humidity

Inactive ingredients

acesulfame potassium, cetylpyridinium chloride, corn syrup, D&C red #33, FD&C red #40, flavors, propylene glycol, purified water, sodium bicarbonate, sucrose

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC 63824-710-16

NEW PACK, SAME RELIEF!

Cēpacol ®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

• Instant Acting

• Maximum Strength Numbing

16 Lozenges

cherry

Cepacol

Cepacol

Benzocaine and Menthol LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-710
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 15 mg
MENTHOL 3.6 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
cetylpyridinium chloride
CORN SYRUP
D&C RED NO. 33
FD&C RED NO. 40
propylene glycol
water
SODIUM BICARBONATE
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
RED 18 mm C ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 8 in 1 BLISTER PACK
4 NDC:63824-710-98 72 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-08-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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