Label: SUCRETS VAPOR CHERRY- dyclonine hydrochloride and menthol lozenge

  • NDC Code(s): 63736-921-18
  • Packager: Insight Pharmaceuticals LLC
  • 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 June 22, 2018

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  • SPL UNCLASSIFIED SECTION

  • Active ingredient (per lozenge)

    Dyclonine hydrochloride 2 mg

    Menthol 6 mg

  • Purpose

    Oral anesthetic

    Cough suppressant

  • Uses

    For temporary relief of occasional:

    • minor irritation
    • pain
    • sore mouth
    • sore throat
  • Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

    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 (1-800-222-1222) right away.

  • Directions

    • do not use more than directed
    • adults and children 4 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist and doctor.
    • children under 4 years of age: ask a dentist and doctor
  • Other information

    • store between 15-30°C (59-86°F)
    • use only if lozenge blister seals are unbroken
  • Inactive ingredients

    cacesulfame potassium, ascorbic acid, citric acid, corn syrup, fd&c red no. 40, liquid sucrose, propylene glycol, sodium ascorbate, tartaric acid, water, wild cherry flavor, zinc gluconate

    ©2017 Distributed by Insight Pharmaceuticals LLC, 
    Tarrytown, NY 10591, a Prestige Brands Company

  • PRINCIPAL DISPLAY PANEL

    SUCRETS® 
    DYCLONINE / ORAL ANESTHETIC • MENTHOL / COUGH SUPPRESSANT
    18 LOZENGES
    VAPOR CHERRY

    PRINCIPAL DISPLAY PANEL 
SUCRETS® 
DYCLONINE / ORAL ANESTHETIC • MENTHOL / COUGH SUPPRESSANT
18 LOZENGES
VAPOR CHERRY

  • INGREDIENTS AND APPEARANCE
    SUCRETS VAPOR CHERRY 
    dyclonine hydrochloride and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-921
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE2 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize19mm
    FlavorCHERRYImprint Code S;Vapor;Cherry
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-921-1818 in 1 CANISTER; Type 0: Not a Combination Product07/28/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/28/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)