Label: SORE THROAT CHERRY- phenol spray

  • NDC Code(s): 63868-811-55
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

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  • Active ingredient

    Phenol 1.4%

  • Purpose

    Oral Anesthetic/Analgesic

  • Uses

    temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • sore mouth symptoms do not improve in 7 days
    • difficulty in breathing occurs

    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

    • apply to affected area
    • use every 2 hours
    • allow to remain in place for at least 15 seconds, then spit out
    agedose 
     adults and children 12 years and over for each application, spray 5 times 
     children 3 to 11 years should be supervised in use of this product for each application, spray 3 times
     children under 3 years ask a doctor or dentist
  • Other information

    • store at 20º-25ºC (68º-77ºF). Do not refrigerate.
  • Inactive ingredients

    alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium

  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the Active Ingredient in Chloraseptic®

    Sore Throat Spray

    Oral anesthetic/analgesic

    Phenol

    Fast acting/long lasting

    Alcohol 0.10%

    Cherry flavor

    FL OZ (mL)

    *This product is not manufactured or distributed by Prestige Brands Inc., distributor of Chloraseptic®.

    TAMPER EVIDENT: DO NOT USE F IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.

    Distributed by C.D.M.A., Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Phenol 1.4%

    Quality Choice Sore Throat Spray

  • INGREDIENTS AND APPEARANCE
    SORE THROAT  CHERRY
    phenol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-811
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-811-55177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02208/31/2014
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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