CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid 
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.

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Cēpacol ®
SORE THROAT SPRAY

Drug Facts

Active ingredientsPurpose
Dyclonine Hydrochloride 0.1%Oral pain reliever
Glycerin 33%Oral demulcent

Uses

for temporary relief of:

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 producttry to avoid swallowing spray.

Directions

Other information

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

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE0.1 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLOXAMER 338 (UNII: F75JV2T505)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-781-74118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/201109/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/20/201109/01/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 9/2023
Document Id: 0650e5e8-122a-6c92-e063-6394a90ac9c0
Set id: af621c32-ec5d-4f5a-ae19-6ff260675ac8
Version: 3
Effective Time: 20230927
 
RB Health (US) LLC