Your browser does not support JavaScript! CEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]
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CEPACOL SORE THROAT (dyclonine hydrochloride and glycerin) liquid
[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 ingredientsPurpose
Dyclonine Hydrochloride 0.1%Oral pain reliever
Glycerin 33%Oral demulcent

Uses

for temporary relief of:

  • occasional minor irritation, pain, sore mouth, and sore throat
  • pain associated with canker sores
  • minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

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.

Stop use and ask a doctor or dentist if

  • sore mouth symptoms do not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Keep 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.

When using this product try to avoid swallowing spray.

Directions

  • adults and children 4 years of age and older: Spray 4 times into throat or affected area. Gargle, swish around or allow to remain in place at least 1 minute and then spit out. Repeat up to 4 times daily or as directed by a dentist or doctor. Children 4 to under 12 years of age should be supervised in the use of this product.
  • children under 4 years of age: do not use

Other information

  • store at room temperature 20-25°C (68-77°F)
  • do not freeze

Inactive ingredients

cetylpyridinium chloride, D&C red #33, deionized water, FD&C yellow #6, flavor, menthol, phosphoric acid, poloxamer 338, potassium sorbate, sodium phosphate dibasic, sorbitol

Questions?

1-888-963-3382

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 63824-781-74

Cēpacol®

SORE THROAT SPRAY

Dyclonine HCl 0.1% • Oral Pain Reliever
Glycerin 33% • Oral Demulcent

Fast Sore Throat Relief

  • Instant Acting
  • Coats & Soothes

4 FL OZ (118 mL)

SUGAR FREE
cherry

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
CEPACOL  SORE THROAT
dyclonine hydrochloride and glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dyclonine Hydrochloride (Dyclonine) Dyclonine Hydrochloride0.1 g  in 100 mL
Glycerin (Glycerin) Glycerin33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
cetylpyridinium chloride 
D&C red No. 33 
water 
FD&C yellow No. 6 
menthol 
phosphoric acid 
poloxamer 338 
potassium sorbate 
sodium phosphate, dibasic 
sorbitol 
Packaging
#Item CodePackage Description
1NDC:63824-781-74118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/20/2011
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2011
Document Id: 1823aecf-9e1f-4029-bf89-2c454ee9a9b0
Set id: af621c32-ec5d-4f5a-ae19-6ff260675ac8
Version: 1
Effective Time: 20110629
 
Reckitt Benckiser LLC

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