FDA.reportPublic FDA data

GUNA SINUS PLUS

Manufacturer
Guna spa
Effective date
2021-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:22

Label at a glance#

ProductGUNA SINUS PLUS
Active ingredientONION, ALTHAEA OFFICINALIS LEAF, SILVER NITRATE, ASCORBIC ACID, HYDRASTIS CANADENSIS WHOLE, LOBARIA PULMONARIA, COPPER, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MANGANESE, MERCURIC SULFIDE, SUS SCROFA NASAL MUCOSA, PULSATILLA VULGARIS, SILICON DIOXIDE, SINUSITISINUM, PLANTAGO MAJOR WHOLE, DRIMIA MARITIMA BULB
Label structure10 sections

Indications and uses

Relieves symptoms of rhinitis and sinusitis such as: runny nose headache mucus buildup nasal congestion

Dosage and administration

Adults and children 12 years and older 2 sprays to each nostril, 3-5 times per day Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day Children under 6 years consult a physician

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older 2 sprays to each nostril, 3-5 times per day



Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day



Children under 6 years consult a physician



ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

  • ALLIUM CEPA 6X, 8X, 12X Relieves hay fever
  • ALTHEA OFFICINALIS 2X Soothing
  • ARGENTUM NITRICUM 10X Relieves cold symptoms
  • ASCORBIC ACIDUM 3X Relieves cold symptoms
  • ECHINACEA 3X Relieves cold symptoms
  • HEPAR SULPHURIS CALCAREUM 6X, 8X, 12X Relieves hay fever
  • HYDRASTIS CANADENSIS 6X, 8X, 12X Relieves mucus buildup
  • KALI BICHROMICUM 6X, 8X, 12X Relieves mucus buildup
  • MERCURIUS SOLUBILIS 8X Relieves mucus buildup
  • MUCOSA NASALIS SUIS 6X, 12X, 30X Relieves stuffy nose
  • PLANTAGO MAJOR 2X Relieves sinus headache
  • PULSATILLA 6X, 8X, 12X Relieves sinus headache
  • SCILLA MARITIMA 12X Relieves nasal discharge
  • SILICEA 6X, 8X, 12X Relieves runny nose
  • SINUSITISINUM 12X, 30X Relieves nasal congestion
  • STICTA PULMONARIA 2X Relieves rhinitis
  • CUPRUM METALLICUM 8X Supports respiratory organs
  • MANGANUM METALLICUM 8X Supports respiratory organs

INDICATIONS & USAGE SECTION

Directions:

tilt head forward slightly, insert the canister tip in the nose, aiming the tip toward the back of the head. Squeeze the pump and spray intro nostril.

INACTIVE INGREDIENT SECTION

Inactive ingredient:purified water, potassium sorbate, sodium benzoate.

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com

Tel. (484) 223-3500


WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health care profesisonal before use

WARNINGS

WARNINGS SECTION

  • Stop use and ask doctor if symptoms persist more than 5 days.
  • If pregnant or breast-feeding ask a health professional before use.
  • Keep out of reach of children. In case of overdose, seek professional assistance or contact a Poison Control Center immediately.

USES

OTC - PURPOSE SECTION

Relieves symptoms of rhinitis and sinusitis such as:

  • runny nose
  • headache
  • mucus buildup
  • nasal congestion

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USSIP-45USSIP-4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5USSIP5USSIP-4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-472-23GUNA SINUS PLUS30 mL in 1 BOTTLE, SPRAYSPRAY301
17089-472-23GUNA SINUS PLUS1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-472GUNA SINUS PLUS (ALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -) SPRAY [GUNA SPA]1Current NDC, Legacy NDC, 2 package rows20210217_b48c5634-24cf-343e-e053-2995a90a3a9a.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-47217089-472-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
ONION492225Q21HACTIB
ALTHAEA OFFICINALIS LEAFE2QQV92338ACTIB
SILVER NITRATE95IT3W8JZEACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
HYDRASTIS CANADENSIS WHOLER763EBH88TACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
COPPER789U1901C5ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
MANGANESE42Z2K6ZL8PACTIB
MERCURIC SULFIDEZI0T668SF1ACTIB
SUS SCROFA NASAL MUCOSAID3Z1X61WYACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SINUSITISINUMB575563DM5ACTIB
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
DRIMIA MARITIMA BULB3629601H5DACTIB

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
GUNA SINUS PLUSALTHAEA OFFICINALIS LEAF - CALCIUM SULFIDE - COPPER - DRIMIA MARITIMA BULB - ECHINACEA ANGUSTIFOLIA - HYDRASTIS CANADENSIS WHOLE - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR WHOLE - POTASSIUM DICHROMATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA -Guna spab48c5634-24cf-343e-e053-2995a90a3a9a2021-02-17WarningsExact identifier
ndc (package): 17089-472-23
ndc (product): 17089-472
ndc11 (package): 17089047223
spl id: b48c5634-24d0-343e-e053-2995a90a3a9a
spl set id: b48c5634-24cf-343e-e053-2995a90a3a9a

Reported adverse events (FAERS/openFDA)#

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