RINOSAN PROPO NASAL DECONGESTANT (EPHEDRINE HYDROCHLORIDE) SPRAY [BEE RIGHT LLC]

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RINOSAN PROPO NASAL DECONGESTANT (EPHEDRINE HYDROCHLORIDE) SPRAY [BEE RIGHT LLC]
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NDC 71952-040-00
Set ID 0bf3e120-ac51-4b14-8584-ab561f6ed446
Category HUMAN OTC DRUG LABEL
Packager Bee Right LLC
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number PART341
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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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