Label: SPRAYOLOGY TRAVELEASE- apis mellifica, carbo vegetabilis, carduus marianus, cocculus indicus, ignatia amara, nux vomica, passiflora incarnata, tabacum 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 January 22, 2014

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients: Apis mellifica 200C, Carbo vegetabilis 200C, Carduus marianus 3X, Cocculus Indicus 30C, Ignatia amara 200C, Nux vomica 30C, Passiflora incarnata 1X, Tabacum 6X.

  • WARNINGS

    Warnings: If symptoms persist or worsen, stop use and 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.

  • PURPOSE

    For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag", including:

    • tiredness
    • dehydration
    • feeling of disorientation
    • sleeplessness

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children over 12: 2 sprays under the tongue at departure, after each 2 hours of flight and on landing. Then 2 sprays 3 times a day until fully acclimated.
    • Children 2 to 12: 1 spray under tongue at departure, after each 2 hours of flight and on landing. Then 1 spray 3 times a day until fully acclimated.
    • Under age 2: consult a health care professional.
  • 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, purified water.

  • INDICATIONS & USAGE

    For use during and after jet travel to temporarily relieve the symptoms commonly known as "jet lag", including:

    ° tiredness

    ° dehydration

    ° feeling of disorientation

    ° sleeplessness

    ° 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 TRAVELEASE 
    apis mellifica, carbo vegetabilis, carduus marianus, cocculus indicus, ignatia amara, nux vomica, passiflora incarnata, tabacum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61096-0007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA200 [hp_C]  in 41 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL200 [hp_C]  in 41 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED3 [hp_X]  in 41 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED30 [hp_C]  in 41 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [hp_C]  in 41 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 41 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]  in 41 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF6 [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:61096-0007-11 in 1 CARTON
    141 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/22/2014
    Labeler - Eight and Company (927364120)
    Registrant - Eight and Company (927364120)