Label: NASAL RELIEF- puraflex nasorelief spray liquid

  • NDC Code(s): 84246-577-30
  • Packager: Shandong Huawei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 15, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    MAGNOLIA BIONDII FLOWER   2%

  • Purpose

    Nasal Decongestant

  • Uses

    For the temporary relief of nasal congestion due to:

    • common cold
    • sinusitis
    • upper respiratory allergies
    • respiratory tract infections
    • weather changes
  • WARNINGS

    Do not use

    • on eyes
    • if excessive irritation develops
    • if allergic to any of the ingredients
  • When using this product

    • do not share dispenser
    • do not exceed recommended dosage
  • Stop use and ask a doctor if

    • condition worsens
    • if symptoms persist.

  • Ask a doctor before use if

    • you have serious chronic diseases
    • you are pregnant or breast-feeding
    • you are menstruating
    • you are using for your children under 3 years of age.
  • Keep out of reach of children. Overdose Warning:

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    • With the head held upright, remove the protective cap.
    • Insert the spray nozzle into the nostril. 
    • Depress the pump completely 1-3 times. 
    • Sniff gently. Repeat up to 3 times daily.
  • Other information

    • Store between 20°-25°C (68°-77°F)

    • The container is filled to proper level for best spray action.

  • Inactive ingredients

    MAGNOLIA BIONDII FLOWER, XANTHIUM SIBIRICUM FRUIT, ANGELICA DAHURICA ROOT, ASARUM HETEROTROPOIDES ROOT, BORNEOL, PURIFIED WATER

  • Questions or comments? (602) 368-7231

    M-F, 9:30 am to 5:30 pm Pacific Time
    You may also report serious side effects to this phone number.

  • Manufactured for Heshoutang Products LLC 

    9035 N 43rd Ave, Phoenix, AZ 85051, USA
    www.heshoutang.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NASAL RELIEF 
    puraflex nasorelief spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84246-577
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNOLIA BIONDII FLOWER (UNII: G1YA92798O) (MAGNOLIA BIONDII FLOWER - UNII:G1YA92798O) MAGNOLIA BIONDII FLOWER2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    ASARUM HETEROTROPOIDES ROOT (UNII: Q94BWI90CD)  
    BORNEOL (UNII: M89NIB437X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84246-577-301 in 1 PACKAGE04/12/2024
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/12/2024
    Labeler - Shandong Huawei Pharmaceutical Co., Ltd. (417377581)
    Registrant - Shandong Huawei Pharmaceutical Co., Ltd. (417377581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Huawei Pharmaceutical Co., Ltd.417377581manufacture(84246-577)