CEPASTAT EXTRA STRENGTH- phenol lozenge 
Insight Pharmaceuticals

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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CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL

Drug Facts

Active ingredient (per lozenge)

Phenol 29 mg

Purpose

Oral Anesthetic

Uses

temporarily relieves

Warnings

When using this product

  • Do not use more than directed.

Stop use and ask a doctor if

  • sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting
  • sore mouth symptoms last more than 7 days, or irritation, pain or redness continues or worsens

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.

Directions

adults and children 12 years and oldertake up to 2 lozenges every 2 hours as needed
children 6 to under 12 yearstake up to 1 lozenge every 2 hours; not more than 10 lozenges in 24 hours
children under 6 yearsask a doctor

Other Information

Store at room temperature, below 86°F (30°C). Protect contents from humidity.

Inactive ingredients

Antifoam Emulsion, Caramel, Eucalyptus Oil, Gum Crystal, Menthol, and Sorbitol.

QUESTIONS?

Call 1-800-344-7239 or visit our website at www.insightpharma.com

Distributed by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 18 Lozenges carton

MENTHOL EUCALYPTUS FLAVOR

CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL

FAST ACTING
SORE THROAT RELIEF
EXTRA STRENGTH*

18 LOZENGES
SUGAR FREE

Principle Display Panel - 18 Lozenges carton
CEPASTAT  EXTRA STRENGTH
phenol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-219
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol29 mg
Inactive Ingredients
Ingredient NameStrength
Caramel (UNII: T9D99G2B1R)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Menthol (UNII: L7T10EIP3A)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorBROWN (transparent) Scoreno score
ShapeROUNDSize19mm
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-219-1818 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/07/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 7/2009
Document Id: a33617f8-fc6a-4c06-8f96-fed5b5d6d570
Set id: 1613c687-411e-487d-b672-a3d849d53e5f
Version: 1
Effective Time: 20090709
 
Insight Pharmaceuticals