Label: SUMMIT SMELLING SALTS inhalant

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated June 16, 2025

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  • ACTIVE INGREDIENT

    Ammonia (15%)

  • PURPOSE

    Inhalant

  • INDICATIONS & USAGE

    To prevent or treat fainting.

  • WARNINGS

    WARNINGS: For external use only. Avoid contact with skin, eyes, and mouth.

  • DO NOT USE

    if allergic, pregnant or have respiratory conditions.

  • WHEN USING

    INSTRUCTIONS:

    1.Shake well before use.

    2.Unscrew cap and hold at least 6 inches from nose.

    3. Inhale slowly no more than 1-2 times per use.

    4.Seal tightly and store in a dark, dry place at room temperature.

    BEFORE USE:

    Remove plastic seal, unscrew cap, and remove foil from mouth of bottle. Reseal lid after each use.

    POTENCY PRESERVATION :

    To maintain potency over time, always seal the lid tightly immediately after each use. Before each session, shake the bottle thoroughly to ensure optimal ammonia activation. For best experience, store the bottle in a dark, dry place at room temperature.

  • STOP USE

    STOP USE AND ASK A DOCTOR if symptoms occur.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If ingested, seek medical attention or contact Poison Control immediately.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Hold bottle at least 6 inches from nose and inhale slowly no more than 1-2 times per use. Avoid repeated inhalationy

  • STORAGE AND HANDLING

    OTHER INFORMATION: Store at room temperature away from light and moisture.

  • INACTIVE INGREDIENT

    Alcohol, Mint Flavor.

  • PRINCIPAL DISPLAY PANEL

    85764-001-01

  • INGREDIENTS AND APPEARANCE
    SUMMIT SMELLING SALTS 
    summit smelling salts inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85764-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MINT (UNII: FV98Z8GITP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85764-001-0140 g in 1 BOX; Type 0: Not a Combination Product06/04/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/04/2025
    Labeler - Washburn Ventures LLC (136693055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washburn Ventures LLC136693055manufacture(85764-001)
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