Label: RINOSAN PROPO NASAL DECONGESTANT- ephedrine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated July 3, 2018

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  • 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 Package4Inner Package4

  • INGREDIENTS AND APPEARANCE
    RINOSAN PROPO NASAL DECONGESTANT 
    ephedrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71952-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71952-040-001 in 1 BOX07/01/2018
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2018
    Labeler - Bee Right LLC (080988303)
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