Air-vita Allergy
FDA Label NDC 54705-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Flutrends International Corporation for the product Air-vita Allergy (NDC 54705-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - 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.

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.

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.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

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

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

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.

Otc - 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

Package Label.Principal Display Panel

Image Description (Airvita Allergy)

Image Description (Airvita Allergy)

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