Label: HOT FLASHES - amyl nitrite, lachesis muta venom and sanguinaria canadensis root pellet

  • NDC Code(s): 68428-020-14
  • Packager: Washington Homeopathic Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/10

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  • ACTIVE INGREDIENTS

    AMYL NIT    6C

    LACHESIS   6C

    SANGUINARIA       6C

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  • USES

    To relieve the symptoms of change of life, night sweats, irritability, fatigue

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

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  • INDICATIONS

    Indications:

    AMYL NIT    Anxiety

    LACHESIS   Sore throat

    SANGUINARIA       Headache Close
  • STOP USE AND ASK DOCTOR

    If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

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  • DIRECTIONS

    Adults 2 pellets every 3 hours for 2 days. Then 2 pellets morning and night for 2 weeks.

    Children: 1 pellet. Repeat as necessary.

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  • INACTIVE INGREDIENTS

    Sucrose/Lactose

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  • PRINCIPAL DISPLAY PANEL

    image of bottle labelEnter section text here

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  • INGREDIENTS AND APPEARANCE
    HOT FLASHES 
    amyl nitrite - lachesis muta venom - sanguinaria canadensis root pellet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68428-020
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMYL NITRITE (AMYL NITRITE) AMYL NITRITE 6 [hp_C]  in 28 g
    LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 6 [hp_C]  in 28 g
    SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 6 [hp_C]  in 28 g
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    LACTOSE  
    Product Characteristics
    Color white (white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68428-020-14 28 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/02/2010
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    Name Address ID/FEI Business Operations
    Washington Homeopathic Products 084929389 manufacture
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