Label: CEPASTAT EXTRA STRENGTH- phenol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated July 9, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per lozenge)

    Phenol 29 mg

  • 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 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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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