CEPACOL SORE THROAT- benzocaine and menthol lozenge

Cepacol by

Drug Labeling and Warnings

Cepacol by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purpose
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

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)
• protects contents from humidity

Inactive ingredients

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

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC: 63824-731-16

Cēpacol®

SORE THROAT

Benzocaine 15 mg | Menthol 2.6 mg
Oral Pain Reliever

• Instant Acting
• Maximum Strength Numbing

16 Lozenges

honey lemon

INGREDIENTS AND APPEARANCE

CEPACOL   SORE THROAT
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-731
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	15 mg
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2.6 mg

Inactive Ingredients
Ingredient Name	Strength
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C yellow no. 6 (UNII: H77VEI93A8)
isomalt (UNII: S870P55O2W)
maltitol (UNII: D65DG142WK)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium bicarbonate (UNII: 8MDF5V39QO)
sucralose (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-731-16	2 in 1 CARTON
1		8 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/21/2011

Labeler - Reckitt Benckiser LLC (094405024)