RINOSAN MINT NASAL DECONGESTANT- ephedrine hydrochloride spray

Rinosan Mint Nasal Decongestant by

Drug Labeling and Warnings

Rinosan Mint Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Apipharmausa, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Ephedrine Hydrochloride 0.5%

Purpose

Nasal Decongestant

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

Warnings

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

• 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

• 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

• symptoms persist

If pregnant or breastfeeding,

consult a health care professional before use.

Keep out of reach of children.

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

Directions

• 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

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

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

RINOSAN MINT NASAL DECONGESTANT 
ephedrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73061-001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73061-001-30	1 in 1 BOX	03/10/2020
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/10/2020

Labeler - Apipharmausa, LLC (117030000)