Label: COLD AND FLU RELIEF- atropine, naja naja venom, magnesium chloride, potassium hydroxide spray

  • 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 January 13, 2021

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  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Contains atropine (Atropinum) 5X HPUS …………………………………....   runny nose relief
    Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief
    Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy
    Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy
    Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

    Contains 24 doses

  • PURPOSE

  • Use

    Temporarily relieves symptoms associated with colds and flu.

  • Warnings

    If symptoms persist or worsen, discontinue use, seek medical attention.
    • Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
    • If pregnant or breastfeeding ask a health professional before use.
    • Consult a medical professional if using other medications for known interactions.
    • The use of this dispenser by more than one person may spread infection.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Do not use if tamperproof cover is missing.
    • Press down 2-3 times to prime the pump.
    • Spray once into each nostril
    • Use 2 times per day to relieve discomfort.
  • Inactive ingredients

    Aspartic acid, benzalkonium chloride, glycerin, propylene glycol, purified water, thiamine.

  • Comments, Questions or Complaints?

    Call 888-735-4009 or info@promedxnow.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU RELIEF 
    atropine, naja naja venom, magnesium chloride, potassium hydroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76524-501
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPINE (UNII: 7C0697DR9I) (ATROPINE - UNII:7C0697DR9I) ATROPINE5 [hp_X]  in 0.2 mL
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM5 [hp_X]  in 0.2 mL
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION5 [hp_X]  in 0.2 mL
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) (HYDROXIDE ION - UNII:9159UV381P) POTASSIUM HYDROXIDE7 [hp_X]  in 0.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    THIAMINE (UNII: X66NSO3N35)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76524-501-185 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/29/2020
    Labeler - PROTEGE' MEDIA LLC (117063923)