Label: SUCRETS- dyclonine hcl, menthol, and pectin lozenge

  • NDC Code(s): 63736-567-18
  • 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 December 15, 2017

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  • ACTIVE INGREDIENT

    Active ingredients (per lozenge)

    Active ingredients (per lozenge)Purpose
     Dyclonine hydrochloride, 2 mg Oral anesthetic/Analgesic
     Menthol, 5 mg Cough suppressant
     Pectin, 6 mg Demulcent

  • Uses

    Temporarily relieves:

    • occasional minor irritation, pain, sore throat, and sore mouth
    • cough associated with a cold or inhaled irritants
    • for protection of irritated areas in sore mouth and 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.

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

  • Directions

    • Do not use more than directed
    • adults and children 4 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 4 years of age: consult a doctor or dentist
  • Other information

    • store between 15°-30°C (59°-86°F)
    • use only if lozenge blister seals are unbroken
    • contains FD&C Yellow No.5 (tartrazine) as a color additive

  • Inactive ingredients

    corn syrup, FD&C yellow no.5, FD&C yellow no.6, honey, lemon oil, propylene glycol, sucrose, tartaric acid, water

  • Questions

    1-800-344-7239

    Sucrets.com

  • PRINCIPAL DISPLAY PANEL

    Sucrets Sore Throat, Cough & Dry Mouth

    Dyclonine/Oral Anesthetic

    Menthol/Cough Suppressant

    Pectin/Dry Mouth

    18 lozenges

    Sucrets Sore Throat, Cough & Sore Throat 18 ct tin

  • INGREDIENTS AND APPEARANCE
    SUCRETS 
    dyclonine hcl, menthol, and pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-567
    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) MENTHOL5 mg
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN6 
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HONEY (UNII: Y9H1V576FH)  
    LEMON OIL (UNII: I9GRO824LL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize19mm
    FlavorLEMON ((Honey Lemon)) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-567-1818 in 1 CAN; Type 0: Not a Combination Product11/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/04/2014
    Labeler - Insight Pharmaceuticals LLC (055665422)
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