Label: SUCRETS SORE THROAT WILD CHERRY- dyclonine hydrochloride lozenge

  • NDC Code(s): 63736-560-18
  • 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 April 4, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (per lozenge)

    Dyclonine hydrochloride, 2 mg

  • Purpose

    Oral anesthetic

  • Uses

    For temporary relief of occasional: 

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

    Sore through 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

    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 the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor
    • children under 4 years of age: ask a dentist or doctor
  • Other information

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

    corn syrup, FD&C blue no 1, FD&C red no 40, flavor, menthol, propylene glycol, sucrose, tartaric acid, water

  • QUESTIONS

    1-800-344-7239 Sucrets.com

  • PRINCIPAL DISPLAY PANEL

    Sucrets Sore Throat
    Dyclonine/Oral Anesthetic
    Wild Cherry
    18 lozenges

    Sucrets Sore Throat Dyclonine/Oral Anesthetic Wild Cherry 18 lozenges

    Sucrets Sore Throat Dyclonine/Oral Anesthetic Wild Cherry 18 lozenges

  • INGREDIENTS AND APPEARANCE
    SUCRETS SORE THROAT WILD CHERRY 
    dyclonine hydrochloride lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize19mm
    FlavorCHERRY (Wild Cherry) Imprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-560-1818 in 1 CONTAINER; 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)
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