CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON- benzocaine and menthol lozenge

Cepacol by

Drug Labeling and Warnings

Cepacol by is a Otc medication manufactured, distributed, or labeled by Atlantic Biologicals Corps. 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 2.6 mg	Oral pain reliever

Uses

Temporary relief of occasional

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

Warnings

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. 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 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.

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

Inactive ingredients

D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Questions?

Call 1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE

INGREDIENTS AND APPEARANCE

CEPACOL   EXTRA STRENGTH SORE THROAT HONEY LEMON
benzocaine and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0732(NDC:63824-732)
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	ORANGE	Score	no score
Shape	ROUND	Size	18mm
Flavor	HONEY (Honey-Lemon)	Imprint Code	S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0732-1	50 in 1 BOX	09/17/2019
1		1 in 1 POUCH; 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 - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-0732) , REPACK(17856-0732)