FDA.reportPublic FDA data

ReBoost

Manufacturer
MediNatura
Effective date
2022-07-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:17:47

Label at a glance#

ProductReBoost
Active ingredientSILVER NITRATE, EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE, LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, PULSATILLA VULGARIS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, ECHINACEA, UNSPECIFIED
Label structure8 sections

Indications and uses

Uses: To temporarily relieve nasal congestion. To reduce cold and flu symptoms such as sinus headache & pressure.

Dosage and administration

Directions: Adults and children 12 years and older: 2 sprays into each nostril every 2-4 hours. Do not exceed 24 sprays in each nostril in 24 hours. Children 4 to 11 years: 1 spray into each nostril every 2-4 hours. Do not exceed 12 sprays into each nostril in 24 hours. For children under 4 years, consult your health professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Anas barbariae 20X, 200C 1%
*Luffa operculata 2X 1%
*Pulsatilla 2X 1%
*Organic Echinacea 3X 1%
*Euphorbium officinarum 4X 1%
*Hydrastis canadensis 5X 1%
Kali bichromicum 6X 1%
Natrum carbonicum 6X 1%
Argentum nitricum 10X 1%
*Hepar sulphuris calcareum 10X 1%

PURPOSE

OTC - PURPOSE SECTION

Relieves nasal congestion
Relieves  post nasal drip
Relieves  sneezing
Relieves sinus headache & pressure
Relieves  runny nose
Relieves nasal itching

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 KEEP OUT OF REACH OF CHILDREN SECTION

Uses

INDICATIONS & USAGE SECTION

Uses: To temporarily relieve nasal congestion.
To reduce cold and flu symptoms such as
sinus headache & pressure.

WARNINGS

WARNINGS SECTION

Warnings: Ask a doctor before use if you
have asthma. In rare cases bronchospasm
may occur in asthmatic patients. Temporary
burning, stinging, sneezing, or increased
nasal discharge may occur. If pregnant or
breast-feeding, ask a health professional
before use. Keep out of reach of children.
The use of this dispenser by more than one
person may spread infection. If symptoms
persist or worsen, a health professional
should be consulted. Do not use if known
sensitivity to ReBoost™ or any of its
ingredients exists.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 12 years
and older: 2 sprays into each nostril every
2-4 hours. Do not exceed 24 sprays in each
nostril in 24 hours. Children 4 to 11 years:
1 spray into each nostril every 2-4 hours.
Do not exceed 12 sprays into each nostril in
24 hours. For children under 4 years,
consult your health professional.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Benzalkonium chloride,
Disodium phosphate dihydrate, Isotonic
sodium chloride solution, Sodium dihydrogen
phosphate dihydrate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReboostReboost

 Add image transcription here...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-4005-9ReBoost1 in 1 CARTONSPRAY14
62795-4005-9ReBoost20 mL in 1 BOTTLE, PUMPSPRAY204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-4005REBOOST (SILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, ECHINACEA UNSPECIFIED, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE AND PULSATILLA VULGARIS) SPRAY [MEDINATURA]4Current NDC, Legacy NDC, 2 package rows20220721_cb8a8d2a-d9d2-4a71-9279-c5641a9126c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-4005-9ML - Milliliter62795-4005f2673402-e8df-4607-be01-c5d4b98e1ec912022-05-04

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-400562795-4005-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER NITRATE95IT3W8JZEACTIB
EUPHORBIA RESINIFERA RESIN1TI1O9028KACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
SODIUM CARBONATE45P3261C7TACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATERN2HC612GYACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
ISOTONIC SODIUM CHLORIDE SOLUTIONVR5Y7PDT5WIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT

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
ReBoostSILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, ECHINACEA UNSPECIFIED, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE AND PULSATILLA VULGARISMediNaturacb8a8d2a-d9d2-4a71-9279-c5641a9126c62022-07-19WarningsExact identifier
ndc (package): 62795-4005-9
ndc (product): 62795-4005
ndc11 (package): 62795400509
spl id: dc9cb3f4-8286-48c3-bfa0-0ed53a3840b1
spl set id: cb8a8d2a-d9d2-4a71-9279-c5641a9126c6

Reported adverse events (FAERS/openFDA)#

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