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 March 10, 2020

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  • 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:

    Bottle2Box

  • INGREDIENTS AND APPEARANCE
    RINOSAN PROPO NASAL DECONGESTANT 
    ephedrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73061-002
    Route of AdministrationNASAL
    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)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73061-002-301 in 1 BOX03/10/2020
    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 finalpart34103/10/2020
    Labeler - Apipharmausa, LLC (117030000)
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