CEPACOL ULTRA SORE THROAT SPRAY - benzocaine and glycerin liquid 
Reckitt Benckiser 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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Drug Facts

Active ingredientsPurpose
Benzocaine 5%Oral pain reliever
Glycerin 33%Oral demulcent

Uses

for the temporary relief of

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, 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 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.

Flammable. Keep away from fire, flame or heat.

When using this product

  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
  • in rare cases, this product may cause a loss of sensation in the throat which is temporary and harmless
  • to avoid swallowing difficulties, avoid eating, chewing gum or sucking on lozenges for 20 minutes after using

Directions

Other information

Inactive ingredients

acesulfame potassium, deionized water, flavors, neotame, polyoxyl-40 hydrogenated castor oil, povidone K90, SD alcohol 38B

Questions?

Call 1-888-963-3382

You may also report side effects to this phone number.

Distributed by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 22.2 mL Bottle Carton

NDC 63824-780-75

Cēpacol®
ULTRA

SORE THROAT SPRAY

Benzocaine 5% | Oral Pain Reliever
Glycerin 33%
| Oral Demulcent

Ultra1 SHOT for Pain Relief
Instant Acting • On-the-Go Comfort

Over 100
Doses

SUGAR FREE
cherry

0.75 FL OZ (22.2 mL)

PRINCIPAL DISPLAY PANEL - 22.2 mL Bottle Carton

CEPACOL  ULTRA SORE THROAT SPRAY
benzocaine and glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-780
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine5 g  in 100 mL
Glycerin (Glycerin) Glycerin33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
WATER 
NEOTAME 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
POVIDONE K90 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63824-780-751 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
122.2 mL in 1 BOTTLEThis package is contained within the CARTON (63824-780-75)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35605/03/2011

Labeler - Reckitt Benckiser LLC (094405024)

Revised: 06/2011 Reckitt Benckiser LLC