Label: AMMONIA INHALANTS inhalant

  • NDC Code(s): 46414-3333-2, 46414-3333-3
  • Packager: James Alexander Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 31, 2019

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  • Drug Facts

  • Active Ingredients (each inhalant)

    Ammonia (15%)

  • Purpose

    inhalant

  • Uses

    To prevent or treat fainting.

  • Warnings

    For external use only.

    Do not use if you have breathing problems such as asthma or emphysema.

    Stop use and ask a doctor if condition persists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Hold inhalant away from face and crush between thumb and forefinger. Carefully approach crushed inhalant to nostrils of affected person.

  • Other Information

    Store at room temperature away from light.

  • Inactive Ingredients

    Alcohol USP, FD&C Red Dye # 40, Lavender Oil FCC, Lemon Oil FCC, Nutmeg Oil FCC, Purified Water USP.

  • Questions?

    Call 1-908-362-9266 Monday through Friday. 9:00am - 5:00pm e.s.t

  • SPL UNCLASSIFIED SECTION

    DISPENSING SOLUTIONS®


    JAMES ALEXANDER CORPORATION
    Blairstown, NJ• (908) 362-9266
    Product information and MSDS available on-line at:
    www.james-alexander.com

    Void of Aqueous

  • Packaging

    image description

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    AMMONIA INHALANTS 
    ammonia inhalants inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-3333
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46414-3333-2100 in 1 CARTON02/14/1976
    1NDC:46414-3333-30.3 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/14/1976
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(46414-3333)