CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol lozenge

Cepacol by

Drug Labeling and Warnings

Cepacol by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

For the temporary relief of occasional

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

Warnings

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or 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.

Do not use

• for teething
• in children 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 out of 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 of age and older: allow one 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

• store at 20-25°C (68-77°F)
• protect contents from humidity

Inactive ingredients

D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

1-866-682-4639
You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC: 63824-713-16
READ ALL WARNINGS

Cēpacol®
EXTRA STRENGTH

#1
DOCTOR
RECOMMENDED†

SORE THROAT
Benzocaine 15 mg Menthol 3.6 mg | Oral Pain Relievers

• Relieves Sore Throat Pain
• Fast Acting
• Maximum Numbing*

16 Lozenges cherry
*based on amount of benzocaine per dose

INGREDIENTS AND APPEARANCE

CEPACOL   EXTRA STRENGTH SORE THROAT CHERRY
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-713
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	15 mg
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	3.6 mg

Inactive Ingredients
Ingredient Name	Strength
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C red no. 40 (UNII: WZB9127XOA)
isomalt (UNII: S870P55O2W)
maltitol (UNII: D65DG142WK)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium bicarbonate (UNII: 8MDF5V39QO)
sucralose (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-713-16	2 in 1 CARTON	07/15/2013
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63824-713-94	1 in 1 CARTON	07/15/2013
2		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 63824-713-04	1 in 1 CARTON	07/15/2013
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/15/2013

Labeler - RB Health (US) LLC (081049410)