Label: AIR-VITA ALLERGY- allium cepa, ambrosia artemisiaefolia, apis mellifica, chamomilla, eucalyptol, eucalyptus globulus, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, natrum muriaticum, nux vomica, quercus robur, silicea, wyethia helenioides liquid

  • NDC Code(s): 54705-000-21
  • Packager: Flutrends International Corporation
  • 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 9, 2015

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  • ACTIVE INGREDIENT

    Drug Facts

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    HPUS active ingredients: Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Chamomilla, Eucalyptol, Eucalyptus globulus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Natrum muriaticum, Nux vomica, Quercus robur, Silicea, Wyethia helenioides.

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  • INDICATIONS & USAGE

    Uses: Temporarily relieves allergy and hay fever symptoms such as: •itchy, watery eyes •sneezing •runny nose •nasal congestion •sinus pressure or headache •post nasal drip •itchy ears, throat or nose

    Natural multi-symptom relief from indoor and seasonal allergies, pollen, ragweed, hay fever, dust, mold, and pet dander.

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  • WARNINGS

    Warnings

    • Do not use if safety seal is broken or missing.
    • Ask a doctor before use if you have a fever or known allergies to any of the listed ingredients.
    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
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  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
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  • DOSAGE & ADMINISTRATION

    Directions:

    • For adults and children 4 years and older: Spray 2 times to throat and spray once into each nostril. Use 1-3 times daily. Use additionally as needed.
    • Maximum benefit may take 1-2 weeks of use.
    • Store at room temperature in a cool, dry place.
    • Once opened, use within six months.

    Throat and Nasal Spray

    1. Remove safety cap and clip.
    2. Hold with thumb at the bottom of bottle and nozzle between your fingers.
    3. Prime pump until liquid dispenses.
    4. Open mouth and spray two times to back of throat.
    5. Looking at your toes, place nozzle tip past the nasal opening.
    6. Spray once in each nostril, tilt head back, let product settle.
    7. Wipe the nozzle clean and replace cap after each use.
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  • INACTIVE INGREDIENT

    Inactive Ingredients: Benzyl alcohol, citric acid, ethanol, glycerin, polozamer 407, potassium phosphate, potassium sorbate, purified water USP, sodium chloride, sodium phosphate, sorbitol, xylitol.

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  • PURPOSE

    Drug Facts

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    HPUS active ingredients                                                                Purpose

    Allium cepa 10X, 30X...................................Runny nose; itchy eyes, ears, nose or throat                                                 

    Ambrosia artemisiaefolia 12X, 30X, LM1..................................Nasal and sinus congestion

    Apis mellifica 30X.................................................................Eases breathing difficulties

    Chamomilla 18X......................................................................Headache and weariness

    Eucalyptol 3X.....................................................................................Nasal congestion

    Eucalyptus globulus 3X...........................Nasal congestion, runny or stuffy nose, headache

    Euphrasia officinalis 12X, 30X, LM1.............................................Sinus pain and pressure

    Galphimia glauca 4X..................................................................Sneezing and hay fever

    Histaminum hydrochloricum 12X, 30X......................................................Sinus pressure

    Natrum muriaticum 10X, 30X............................Loss of smell and taste, itchy, watery eyes

    Nux vomica 15X...........................................................................Itchy nose and throat

    Quercus robur 4X.............................................................................Puffy eyes, vertigo

    Silicea 8X, 30X.............................................................Runny or blocked nose, sneezing

    Wyethia helenioides 12X, 30X, LM1...............................Post nasal drip, bronchial irritation

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  • INGREDIENTS AND APPEARANCE
    AIR-VITA ALLERGY 
    allium cepa, ambrosia artemisiaefolia, apis mellifica, chamomilla, eucalyptol, eucalyptus globulus, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, natrum muriaticum, nux vomica, quercus robur, silicea, wyethia helenioides liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54705-000
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 10 [hp_X]  in 28 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA 12 [hp_X]  in 28 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 30 [hp_X]  in 28 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 18 [hp_X]  in 28 mL
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL 3 [hp_X]  in 28 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 3 [hp_X]  in 28 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 12 [hp_X]  in 28 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 4 [hp_X]  in 28 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [hp_X]  in 28 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 10 [hp_X]  in 28 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X]  in 28 mL
    QUERCUS ROBUR TWIG BARK (UNII: 2JFK226947) (QUERCUS ROBUR TWIG BARK - UNII:2JFK226947) QUERCUS ROBUR TWIG BARK 4 [hp_X]  in 28 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 8 [hp_X]  in 28 mL
    WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N) WYETHIA HELENIOIDES ROOT 12 [hp_X]  in 28 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54705-000-21 28 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/28/2014
    Labeler - Flutrends International Corporation (054162682)
    Registrant - Flutrends International Corporation (054162682)
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