FDA.reportPublic FDA data

Rinosan Mint Nasal Decongestant Spray

Manufacturer
Apipharmausa, LLC
Effective date
2022-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:50:59

Label at a glance#

ProductRinosan Mint Nasal Decongestant
Active ingredientEPHEDRINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

temporarily relieves nasal congestion due to the common cold, hay fever (allergic rhinitis) temporarily relieves stuffy nose temporarily restores freer breathing through the nose reduces swelling of nasal passages; shrinks swollen membranes helps decongest sinus openings and passages; promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure

Dosage and administration

 Adults and children 12 year of age and over  2 or 3 sprays in each nostril not more than once every 4 hours  Children 6 to under 12 years of age (with adult supervision)  1 or 2 sprays in each nostril not more than once every 4 hours  Children under 6 years of age  Consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ephedrine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to the common cold, hay fever (allergic rhinitis)
  • temporarily relieves stuffy nose
  • temporarily restores freer breathing through the nose
  • reduces swelling of nasal passages; shrinks swollen membranes
  • helps decongest sinus openings and passages;
  • promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Consult a doctor before use if you have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When using this product

OTC - WHEN USING SECTION

  • use of this container by more than one person may spread infection
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge

do not use

OTC - DO NOT USE SECTION

  • this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • do not exceed recommended dosage

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • symptoms persist

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults and
children 12 year
of age and over 		 2 or 3 sprays in
each nostril not
more than once
every 4 hours
 Children 6 to
under 12 years
of age (with adult
supervision) 		 1 or 2 sprays in
each nostril not
more than once
every 4 hours
 Children under 6
years of age 		 Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store in a dry and dark place at room temperature
  • use within 30 days of opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, propolis extract, sodium chloride, water, xanthan gum

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2Box2Box2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73061-00173061-001-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPOLIS WAX6Y8XYV2NOFIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
EPHEDRINE HYDROCHLORIDENLJ6390P1ZACTIB

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
09d0a7c6-ed98-0036-e063-6294a90a2085cc0ae13b-475f-4ae5-aa4b-b3dac424c56e2023-11-10WarningsExact identifier
spl set id: cc0ae13b-475f-4ae5-aa4b-b3dac424c56e

Reported adverse events (FAERS/openFDA)#

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