CEPASTAT CHERRY- phenol lozenge 
Insight Pharmaceuticals 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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CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL

Drug Facts

Active ingredient (per lozenge)

Phenol 14.5mg

Purpose

Oral Anesthetic

Uses

temporarily relieves

  • minor sore throat pain
  • sore mouth
  • minor mouth irritation
  • pain associated with canker sores

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

  • dissolve a lozenge slowly in mouth
 adults and children 12 years and older take up to 2 lozenges every 2 hours as needed
 children 6 to under 12 years take up to 1 lozenge every 2 hours; not more than 18 lozenges in 24 hours
 children under 6 years ask a doctor

Other Information

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

Inactive ingredients

Antifoam Emulsion, D&C Red No.33, FD&C Yellow No.6, Flavor, Gum Crystal, Menthol, Saccharin Sodium, 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

CHERRY

CĒPASTAT®
ORAL ANESTHETIC WITH PHENOL

FAST ACTING
SORE THROAT RELIEF

18 LOZENGES
SUGAR FREE

Principle Display Panel - 18 Lozenges Carton
CEPASTAT  CHERRY
phenol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL14.5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPINK (Hot Pink) Scoreno score
ShapeROUNDSize19mm
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-204-1818 in 1 BOX; Type 0: Not a Combination Product06/29/200908/31/2017
2NDC:63736-204-97648 in 1 BOX; Type 0: Not a Combination Product06/29/200908/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/29/200908/31/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 7/2009
Document Id: c626ce4a-1897-471e-bcff-cd3717ba6c53
Set id: 6f4402aa-3f6e-4469-b512-868dba734d2b
Version: 3
Effective Time: 20090709
 
Insight Pharmaceuticals LLC