Label: SUCRETS COMPLETE VAPOR CHERRY- dyclonine hydrochloride and menthol 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 August 4, 2009

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  • Active ingredient (per lozenge)

    Dyclonine Hydrochloride 3.0 mg

    Menthol 6.0 mg

  • Purpose

    Oral Anesthetic/Analgesic

    Cough Suppressant

  • Uses

    temporarily relieves:

    • occasional minor irritation, pain, sore throat and sore mouth
    • cough associated with a cold or inhaled irritants
  • Warnings

    Sore throat warning

    Severe or persistent sore throat or sore throat that occurs with or is followed by high fever, headache, rash, swelling and nausea may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops
    • cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition.

    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 2 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.
    • children under 2 years of age: consult a doctor or dentist.
  • Other Information

    Avoid storing at high temperature (greater than 100°F).
    Use only if lozenge blister seals are unbroken

  • Inactive ingredients

    Corn Syrup, Sucrose, Water, Propylene Glycol, Citric Acid, Zinc Gluconate, Tartaric Acid, Sodium Ascorbate, Acesulfame Potassium, Ascorbic Acid, Cherry Flavor, FD&C Red #40.

  • QUESTIONS

    CALL 1-800-344-7239
    www.insightpharma.com

  • SPL UNCLASSIFIED SECTION

    DIST. BY: INSIGHT PHARMACEUTICALS CORP.
    LANGHORNE, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 18 Lozenges Container

    GUARANTEED...Made Stronger To Last Longer!®

    SUCRETS®
    COMPLETE

    DYCLONINE / ORAL ANESTHETIC • MENTHOL / COUGH SUPPRESSANT

    • Suppresses Cough
    • Serious Sore Throat Relief
    • Cools Nasal Passages
    • Fights Bad Breath

    PLUS Vitamin C and Zinc

    18 LOZENGES

    VAPOR CHERRY

    65970B

    Principle Display Panel - 18 Lozenges Container
  • PRINCIPAL DISPLAY PANEL - 24 Lozenges Container

    GUARANTEED...Made Stronger To Last Longer!®

    SUCRETS®
    COMPLETE

    DYCLONINE / ORAL ANESTHETIC • MENTHOL / COUGH SUPPRESSANT

    • Suppresses Cough
    • Serious Sore Throat Relief
    • Cools Nasal Passages
       
      PLUS
      Vitamin C and Zinc

    BONUS 33% MORE
    24 Lozenges     for the price of 18 Lozenges

    24 LOZENGES

    VAPOR CHERRY

    66019A

    Principle Display Panel - 24 Lozenges Container
  • PRINCIPAL DISPLAY PANEL - Back Label

    Principle Display Panel - Back Label
  • INGREDIENTS AND APPEARANCE
    SUCRETS COMPLETE  VAPOR CHERRY
    dyclonine hydrochloride and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-920
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dyclonine Hydrochloride (UNII: ZEC193879Q) (Dyclonine - UNII:078A24Q30O) Dyclonine Hydrochloride3 mg
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol6 mg
    Inactive Ingredients
    Ingredient NameStrength
    Corn Syrup (UNII: 9G5L16BK6N)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Tartaric Acid (UNII: W4888I119H)  
    Sodium Ascorbate (UNII: S033EH8359)  
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize19mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-920-1818 in 1 CANISTER
    2NDC:63736-920-2424 in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2009
    Labeler - Insight Pharmaceuticals (176792315)
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