Label: SORE THROAT- echinacea purpurea, plantago major, baptisia tinctoria spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 29, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Echinacea purpurea 2X, Plantago major 2X, Baptisia tinctoria 3X, Phytolacca decandra 3X, Apil mellifica 12X, Belladonna 12X, Lachesis mutus 12X, Mercurius solubilis 12X, Hepar sulphuris calcareum 15X.

  • PURPOSE

    INDICATIONS:  For the symptomatic relief of monor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.

  • WARNINGS

    WARNINGS:  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.  Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.




    WARNING:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a physician promptly.  Do not use more that two days or administer to children under 3 years of age unless directed by a physician.



    Recommended for Professional Use.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Adults and children over 12 years of age, at onset of symptoms, spray throat every 3 hours.  Consult a physician for use in children under 12 years of age.

    To be used according to standard homeopathic indications or as directed by a homeopathic physician.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow flavor, Menthol, Spearmint oil, Stevia 90% Powered Extract, Teaberry oil.


  • QUESTIONS

    Manufactured Exclusively For:

    NSI and Nova Aurora Corp

    Pittsburgh, PA 15209

    www.phpltd.com

  • PRINCIPAL DISPLAY PANEL

    PROFESSIONAL HEALTH PRODUCTS

    SORE THROAT SPRAY

    HOMEOPATHIC

    C63 (reorder code)

    NET 1 FL. OZ. (30 ML)

    Sore Throat Spray

  • INGREDIENTS AND APPEARANCE
    SORE THROAT  
    echinacea purpurea, plantago major, baptisia tinctoria spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0157
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR2 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE (UNII: K48IKT5321)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    MYRRH (UNII: JC71GJ1F3L)  
    SAGE (UNII: 065C5D077J)  
    THYME (UNII: CW657OBU4N)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMARSHMALLOW (Marshmallow flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0157-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/25/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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