Cepacol description, usages, side effects, indications, overdosage, supplying and lots more!

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Cepacol

Reckitt Benckiser LLC

Cēpacol SORE THROAT & COATING


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each lozenge) Purpose
Benzocaine 15 mg Oral pain reliever
Pectin 5 mg Oral demulcent

Cepacol Uses

temporarily

  • relieves occasional minor irritation, pain and discomfort of sore throat and sore mouth
  • protects irritated areas in sore throat and sore mouth

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 6 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 6 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 6 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, D&C yellow #10, FD&C blue #1, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate

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 63824-750-16

NEW PACK, SAME RELIEF!

Cēpacol ®

SORE THROAT & COATING

Benzocaine 15 mg | Pectin 5 mg
Oral Pain Reliever
| Oral Demulcent

  • Instant Acting
  • Maximum Strength Numbing

16 Lozenges

SUGAR FREE
lemon lime

Cepacol

Cepacol

Benzocaine and Pectin LOZENGE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63824-750
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 15 mg
PECTIN 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
cetylpyridinium chloride
D&C YELLOW NO. 10
FD&C BLUE NO. 1
ISOMALT
MALTITOL
propylene glycol
water
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
GREEN 18 mm C ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:63824-750-16 2 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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