Your browser does not support JavaScript! CEPACOL SORE THROAT (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]
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RxNorm Names

CEPACOL SORE THROAT (benzocaine and menthol) lozenge
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients (in each lozenge)Purposes
Benzocaine 15 mgOral pain reliever
Menthol 3.6 mgOral 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)
  • protect contents from humidity

Inactive ingredients

D&C Red #33, FD&C Red #40, 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.

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

Made in England

PRINCIPAL DISPLAY PANEL - 16 Lozenge Carton

NDC 63824-712-16

NEW FORMULA!

CÄ“pacol®

SORE THROAT

Benzocaine 15 mg | Menthol 3.6 mg
Oral Pain Reliever

  • Instant Acting
  • Maximum Strength Numbing

16 Lozenges
cherry

Principal Display Panel - 16 Lozenge Carton
CEPACOL   SORE THROAT
benzocaine and menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-712
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine15 mg
Menthol (Menthol) Menthol3.6 mg
Inactive Ingredients
Ingredient NameStrength
D&C red no. 33 
FD&C red no. 40 
isomalt 
maltitol 
propylene glycol 
water 
sodium bicarbonate 
sucralose 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize18mm
FlavorCHERRYImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-712-162 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:63824-712-9872 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:63824-712-941 in 1 CARTON
34 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35603/15/2013
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 3/2013
 
Reckitt Benckiser LLC

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