CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol, unspecified form lozenge

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5), Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)
Available from:
RB Health (US) LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of occasional - sore throat - sore mouth - minor irritation - pain - pain associated with canker sores
Authorization status:
OTC monograph not final
Authorization number:
63824-715-16, 63824-715-36

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY- benzocaine and menthol,

unspecified form lozenge

RB Health (US) 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.

----------

Cēpacol

Extra Strength Sore Throat Cherry

Drug Facts

Active ingredients (in each

lozenge)

Purposes

Benzocaine 15 mg

Oral pain reliever

Menthol 3.6 mg

Oral pain reliever

Us es

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, purified water, sodium bicarbonate,

sucralose

Ques tions ?

1-866-682-4639

You may also report side effects to this phone number.

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in India

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton

NDC 63824-715-16

READ ALL WARNINGS

Cēpacol

EXTRA STRENGTH

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

CEPACOL EXTRA STRENGTH SORE THROAT CHERRY

benzocaine and menthol, unspecified form lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 24-715

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benzo ca ine (UNII: U3RSY48 JW5) (Benzo caine - UNII:U3RSY48 JW5)

Be nz o c a ine

15 mg

Mentho l, Unspecified Fo rm (UNII: L7T10 EIP3A) (Mentho l, Unspecified Fo rm -

UNII:L7T10 EIP3A)

Mentho l, Unspecified

Fo rm

3.6 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ISO MALT (UNII: S8 70 P55O2W)

MALTITO L (UNII: D6 5DG142WK)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

no sco re

S hap e

ROUND

S iz e

18 mm

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 38 24-715-16

2 in 1 CARTON

0 3/30 /20 18

1

8 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 38 24-715-36

3 in 1 CARTON

0 5/0 1/20 19

2

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part356

0 3/30 /20 18

RB Health (US) LLC

Labeler -

RB Health (US) LLC (081049410)

Revised: 3/2020

Similar products

Search alerts related to this product

View documents history

Share this information