Prevencia Nasal Spray

Manufacturer
Core Consumer Healthcare LLC | Dennis O'Donnell
Effective date
2022-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:18

Label at a glance#

ProductPREVENCIA
Active ingredientFUCUS VESICULOSUS, BOS TAURUS COLOSTRUM
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts Labeling

OTC - ACTIVE INGREDIENT SECTION

active ingredient sectionactive ingredient sectionDrug Facts

Active ingredients Purpose

Fucus vesiculosus (Fucoidan) HPUS 3X Natural antiviral

Colostrum sarcodes HPUS 3X Natural antiviral

The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States (HPUS).

Warnings

For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and ­­­seek medical help right away.

Ask a doctor before use if you have ear, nose, or throat sensitivity or susceptibility to nosebleeds.

When using this product

if accidental eye contact, skin irritation, or rash occurs, rinse with water and discontinue use
use of this container by more than one person may spread infection
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if

symptoms get worse or last more than 7 days or accompanied by fever
redness or swelling is present * new symptoms occur

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions

Adults and children 12 years of age and older:

Shake well before using. Remove cap and clip. Before using for the first time, prime pump by depressing the rim a few times for the fine mist to appear.
Without tilting head, place tip of nozzle in the nostril. Without inhaling, depress the rim and pump once into each nostril. Do not overspray.
Wipe away any excess.
Use every 4 to 6 hours.

Other information * store at room temperature 15-29° (59-84°F)

Inactive ingredients aloe vera, benzalkonium chloride, carboxymethylcellulose sodium, cetrimonium chloride, deionized water, menthol, polyquaternium-22, potassium sorbate, propylene glycol, sodium phosphate, and xanthan gum.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older:

Shake well before using. Remove cap and clip. Before using for the first time, prime pump by depressing the rim a few times for the fine mist to appear.
Without tilting head, place tip of nozzle in the nostril. Without inhaling, depress the rim and pump once into each nostril. Do not overspray.
Wipe away any excess.
Use every 4 to 6 hours.

Warnings

WARNINGS SECTION

Warnings

For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and ­­­seek medical help right away.

Ask a doctor before use if you have ear, nose, or throat sensitivity or susceptibility to nosebleeds.

When using this product

if accidental eye contact, skin irritation, or rash occurs, rinse with water and discontinue use
use of this container by more than one person may spread infection
temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if

symptoms get worse or last more than 7 days or accompanied by fever
redness or swelling is present * new symptoms occur

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera, benzalkonium chloride, carboxymethylcellulose sodium, cetrimonium chloride, deionized water, menthol, polyquaternium-22, potassium sorbate, propylene glycol, sodium phosphate, and xanthan gum.

Indications and Usage

INDICATIONS & USAGE SECTION

Use to reduce risk of cold and flu infections

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

OTC Purpose

OTC - PURPOSE SECTION

Reduce risk of cold and flu infections

Prevencia Nasal Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front panelfront panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82506-100-152023-07-28C16284748780-10191ceaa-68cf-198a-e063-dbdaa90aec3ePrevencia Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82506-100-15PREVENCIA15 mL in 1 BOTTLE, SPRAYSPRAY151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82506-100PREVENCIA (FUCUS VESICULOSUS, BOVINE COLOSTRUM) SPRAY [CORE CONSUMER HEALTHCARE LLC]1Legacy NDC, 1 package rows20221018_eac52476-a13f-6a97-e053-2995a90a2dfb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82506-10082506-100-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eac52476-a140-6a97-e053-2995a90a2dfbeac52476-a13f-6a97-e053-2995a90a2dfb2022-10-11WarningsExact identifier
spl id: eac52476-a140-6a97-e053-2995a90a2dfb
spl set id: eac52476-a13f-6a97-e053-2995a90a2dfb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.