Label: AMMONIA INHALANTS- ammonia inhalant

  • 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 4, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient: Ammonia 15%

  • PURPOSE

    Purpose:

    Reflex Stimulant

  • INDICATIONS & USAGE

    Uses:

    to aid in prevention and treatment of fainting

  • WARNINGS

    Warnings:

    For external use only

    Flammable, keep away from heat or flame

  • DO NOT USE

    Do not use:

    • if face is flush
    • in or near the eyes
    • if you have breathing problems such as asthma or emphysema
  • STOP USE

    Stop use and ask a doctor if:

    • patient is non-responsive
    • condition lasts
  • 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. 1-800-1222

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:

    • hold away from face and crush inhalant between fingers
    • hold packet six inches from patient's nose
    • gradually move inhalant closer until patient revives
    • check strength frequently by holding near your own nose
    • if necessary, use another when first is expended
    • dispose of properly

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: alcohol USP, FD&C red dye #40, lavender oil FCC, lemon oil FCC, nutmeg oil FCC, purified water USP

  • PRINCIPAL DISPLAY PANEL

    0510ammoniav20f.jpg

  • INGREDIENTS AND APPEARANCE
    AMMONIA INHALANTS 
    ammonia inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0054
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.15 g  in 1 g
    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:50332-0054-110 in 1 BOX01/04/2021
    1.15 g in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2000
    Labeler - HART Health (069560969)