Cēpacol® Extra Strength Sore Throat Cherry

Cēpacol® Extra Strength Sore Throat Cherry

Drug Labeling and Warnings

Drug Details

k">

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 mgOral pain reliever
Menthol 3.6 mgOral 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, purified water, sodium bicarbonate, sucralose

Questions?

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

Sugar Free

For Institutional Use – Not For Resale
READ ALL WARNINGS

NDC: 63824-724-82

Cēpacol®
EXTRA STRENGTH

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Relievers

cherry

16 Lozenges

PRINCIPAL DISPLAY PANEL - 16 Lozenge Blister Pack Carton
CEPACOL EXTRA STRENGTH SORE THROAT CHERRY 
benzocaine and menthol, unspecified form lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-724
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine15 mg
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form3.6 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ISOMALT (UNII: S870P55O2W)  
MALTITOL (UNII: D65DG142WK)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63824-724-8324 in 1 CASE03/30/2018
1NDC: 63824-724-822 in 1 CARTON
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2018
Labeler - RB Health (US) LLC (081049410)

Revised: 5/2019
 
RB Health (US) LLC


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.