Label: SLEEP DISORDER DROPS 2152- sleep disorder drops liquid

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 15, 2019

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  • ACTIVE INGREDIENTS

    Chamomilla 3X
    Panax ginseng 3X
    Passiflora incarnata 3X
    Schisandra 3X
    Succinum 3X
    Rauwolfia serpentina 6X
    Graphites 8X
    Aconitum napellus 9X
    Baryta carbonica 9X
    Phosphorus 9X
    Arnica montana 12X
    Sulphur 12X
    Arsenicum album 30X
    Mercurius solubilis 30X
    Sepia 30X

  • QUESTIONS

    Professional Formulas

    PO Box 2034 Lake Oswego, OR 97035

  • INDICATIONS

    For the temporary relief of unrestful, interrupted, or inconsistent sleep.*

  • PURPOSE

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS

    In case of overdose, get medical help or contact a poison control center right away.

    Keep out of the reach of children.

    If pregnant or breastfeeding, ask a healthcare professional before use.

  • DIRECTIONS

    Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

  • OTHER INFORMATION

    Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

  • INACTIVE INGREDIENTS

    20% ethanol, purified water.

  • LABEL

    Est 1985

    Professional Formulas

    Complementary Health

    Sleep Disorder Drops

    Homeopathic Remedy

    2 FL. OZ. (59 mL)

    Label image

  • INGREDIENTS AND APPEARANCE
    SLEEP DISORDER DROPS  2152
    sleep disorder drops liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63083-2152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARTEMISIA ANNUA FLOWERING TOP (UNII: 0UQK6O82OW) (ARTEMISIA ANNUA FLOWERING TOP - UNII:0UQK6O82OW) ARTEMISIA ANNUA FLOWERING TOP3 [hp_X]  in 59 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG3 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 59 mL
    SCHISANDRIN B, (+/-)- (UNII: 02XA4X3KZW) (SCHISANDRIN B, (+/-)- - UNII:02XA4X3KZW) SCHISANDRIN B, (+/-)-3 [hp_X]  in 59 mL
    AMBER (UNII: 70J9Z0J26P) (AMBER - UNII:70J9Z0J26P) AMBER3 [hp_X]  in 59 mL
    RAUWOLFIA SERPENTINA (UNII: H192N84N1G) (RAUWOLFIA SERPENTINA - UNII:H192N84N1G) RAUWOLFIA SERPENTINA6 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE8 [hp_X]  in 59 mL
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE9 [hp_X]  in 59 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE9 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS9 [hp_X]  in 59 mL
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE12 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]  in 59 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63083-2152-259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/1985
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/1984
    Labeler - Professional Complementary Health Formulas (167339027)
    Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Pharmaceutical Manufacturing LLC015624923manufacture(63083-2152)
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