Label: HOMEOPATHIC MOON DROPS- arsenic cation 30x, matricaria chamomilla 6x, arabica coffee bean 12x, gelsemium sempervirens root 12x, strychnos ignatii seed 30x, lycopodium clavatum spore 30x, sodium chloride 30x, strychnos nux vomica seed 30x, valerian 12c, lozenge

  • NDC Code(s): 57556-008-01
  • Packager: Historical Remedies LLP
  • 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 May 14, 2020

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  • Indication

    Helps relieve occasional sleeplessness by soothing the mind, and easing you into a natural sleep. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • PURPOSE

  • Directions

    Adults and children over 8: Dissolve one Moon Drops lozenge in mouth. Repeat every half hour as needed.

  • Warnings

    If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children’s reach. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breast-feeding, ask a doctor before use.
    Do not use if shrink wrap is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN

  • Active Ingredients (HPUS)

    Arsenicum alb 30X, Chamomilla 6X, Coffea cruda 12X, Gelsemium 12C, Ignatia 30X, Lycopodium 30X, Nat mur 30X, Nux vom 30X, Valeriana 12C. 

  • Inctive Ingredients

    Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Organic Vanilla Flavor.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC MOON DROPS 
    arsenic cation 30x, matricaria chamomilla 6x, arabica coffee bean 12x, gelsemium sempervirens root 12x, strychnos ignatii seed 30x, lycopodium clavatum spore 30x, sodium chloride 30x, strychnos nux vomica seed 30x, valerian 12c, lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57556-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_C]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ACHLYS TRIPHYLLA WHOLE (UNII: 91THU5EJ2I)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57556-008-0130 in 1 BOX; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - Historical Remedies LLP (627758634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medinatura New Mexico, inc.102783016manufacture(57556-008)