CEPACOL SORE THROAT - benzocaine and menthol lozenge
Reckitt Benckiser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

Other information

tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
store at room temperature 20-25°C (68-77°F)
protect contents from humidity

Inactive ingredients

acesulfame potassium, D&C red #33, FD&C red #40, flavors, glucose, 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 63824-711-16

Cēpacol®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

Instant Acting
Maximum Strength Numbing

16 Lozenges

cherry

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

CEPACOL SORE THROAT
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-711
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (Benzocaine)	Benzocaine	15 mg
Menthol (Menthol)	Menthol	3.6 mg

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium
D&C red no. 33
FD&C red no. 40
dextrose
propylene glycol
water
sodium bicarbonate
sucrose

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	18mm
Flavor	CHERRY	Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63824-711-16	2 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		8 LOZENGE in 1 BLISTER PACK	This package is contained within the CARTON (63824-711-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/01/2011	06/12/2012

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2012 Reckitt Benckiser LLC