Label: SLEEP AID (adenosinum triphosphoricum dinatrum, pantothenic acid, pineal gland (suis), sarcolacticum acidum, ubidecarenonum, l-tryptophan, melatonin, pyrrole, arsenicum album, avena sativa, chamomilla, coffea cruda, mercurius corrosivus, passiflora incarnata, silicea, zincum valerianicum, dysentery bacillus, gaertner bacillus- bach 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 July 16, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Adenosinum Triphosphoricum Dinatrum 8X, Pantothenic Acid 8X, Pineal Gland (Suis) 8X, Sarcolacticum Acidum 8X, Ubidecarenonum 8X, L-Tryptophan, Melatonin 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Pyrrole 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C , Arsenicum Album 10X, 30X, 1LM, Avena Sativa 10X, 30X, 1LM, Chamomilla 10X, 30X, 1LM, Coffea Cruda 10X, 30X, 1LM, Mercurius Corrosivus 10X, 30X, 1LM, Passiflora Incarnata 10X, 30X, 1LM, Silicea 10X, 30X, 1LM, Zincum Valerianicum 10X, 30X, 1LM, Dysentery Bacillus 30C, Gaertner Bacillus (Bach) 30C.

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of the symptoms of sleeplessness such as tiredness, fatigue, and lack of energy.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, ask a healthcare professional before use.

    Tamper seal: "Sealed for Your Protection."

    Do not use if seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    1-10 drops under the tongue, 3 times a day or as directed by your health professional. Consult a physician for use in children under 12 years of age.

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of the symptoms of sleeplessness such as tiredness, fatigue, and lack of energy.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    demineralized water, 25% ethanol

  • QUESTIONS:

    Distributed by

    Pro Weight Loss Inc., 94 Boylston Cir.

    Shrewsbury, MA 01545 • 877-323-0107

  • PACKAGE LABEL DISPLAY:

    NDC 70558-0011-1

    Pro Weight Loss

    HOMEOPATHIC

    Sleep Aid

    1 FL OZ (30 ml)

    Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    adenosinum triphosphoricum dinatrum, pantothenic acid, pineal gland (suis), sarcolacticum acidum, ubidecarenonum, l-tryptophan, melatonin, pyrrole, arsenicum album, avena sativa, chamomilla, coffea cruda, mercurius corrosivus, passiflora incarnata, silicea, zincum valerianicum, dysentery bacillus, gaertner bacillus (bach) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70558-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM8 [hp_X]  in 1 mL
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID8 [hp_X]  in 1 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND8 [hp_X]  in 1 mL
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-8 [hp_X]  in 1 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE8 [hp_X]  in 1 mL
    TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN8 [hp_X]  in 1 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN8 [hp_X]  in 1 mL
    PYRROLE (UNII: 86S1ZD6L2C) (PYRROLE - UNII:86S1ZD6L2C) PYRROLE8 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE10 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 1 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE10 [hp_X]  in 1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 1 mL
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE10 [hp_X]  in 1 mL
    SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE30 [hp_C]  in 1 mL
    SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70558-0011-130 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/16/2021
    Labeler - Pro Weight Loss Inc. (080166665)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(70558-0011) , api manufacture(70558-0011) , label(70558-0011) , pack(70558-0011)