Label: SPRAYOLOGY DIGESTIVEASE- arsenicum album, calcarea sulphurica, carbo animalis, carbo vegetabilis, cinchona officinalis, hydrastis canadensis, nox vomica, ornithogalum, pyrogenium, silicea liquid

  • 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 March 17, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients: Arsenicum album 200C, Calcarea sulphurica 200C, Carbo animalis 12X, Carbo vegetabilis 12X, Cinchona officinalis 200C, Hydrastis canadensis 12X, Nox vomica 200C, Ornithogalum 12X, Pyrogenium 200, Silicea 12X

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children over 12: 2 sprays into the mouth each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
    • Ages 2 to 12: 1 spray into the mouth each 30 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter. Under age 2: consult a health care professional.
  • PURPOSE

    Temporarily relieves symptoms of gastric distress, including:

    • nausea and food poisoning
    • flatulence
    • indigestion and heartburn
    • stomach cramps
  • OTHER SAFETY INFORMATION

    Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

  • INDICATIONS & USAGE

    Temporarily relieves symptoms of gastric distress, including:

    ° nausea and food poisoning

    ° flatulence

    ° indigestion and heartburn

    ° stomach cramps

    ° natural

    ° gluten free

    ° no artificial flavors or colors

    ° no known negative side effects

    ° no known negative drug interactions

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPRAYOLOGY DIGESTIVEASE 
    arsenicum album, calcarea sulphurica, carbo animalis, carbo vegetabilis, cinchona officinalis, hydrastis canadensis, nox vomica, ornithogalum, pyrogenium, silicea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE200 [hp_C]  in 41 mL
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS200 [hp_C]  in 41 mL
    CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS12 [hp_X]  in 41 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 41 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK200 [hp_C]  in 41 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL12 [hp_X]  in 41 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED200 [hp_C]  in 41 mL
    ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM12 [hp_X]  in 41 mL
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF200 [hp_C]  in 41 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 41 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61096-0005-11 in 1 CARTON
    141 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/17/2014
    Labeler - Eight and Company (927364120)
    Registrant - Eight and Company (927364120)