Rinosan PROPO Nasal Decongestant: Package Insert and Label Information

RINOSAN PROPO NASAL DECONGESTANT- ephedrine hydrochloride spray
Bee Right LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient

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:

Outer Package4
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Inner Package4
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RINOSAN PROPO NASAL DECONGESTANT
ephedrine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71952-040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM CHLORIDE
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71952-040-00 1 BOTTLE, SPRAY in 1 BOX contains a BOTTLE, SPRAY
1 30 mL in 1 BOTTLE, SPRAY This package is contained within the BOX (71952-040-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/01/2018
Labeler — Bee Right LLC (080988303)

Revised: 07/2018 Bee Right LLC

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