Label: SLEEP TIGHT (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 January 21, 2020

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 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 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 the temporary relief of sleeplessness such as tiredness, fatigue, and lack of energy.**

    **These statements are based upon 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 health 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:

    10 drops under the tongue, 3 to 6 times per day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

  • HOMEOPATHIC INDICATIONS:

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

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

  • INACTIVE INGREDIENTS:

    demineralized water, 25% ethanol

  • QUESTIONS:

    Distributed by Dr. Donna Restivo DC, Wellness Consultant

    822 South Lake Blvd. Mahopac, New York 10541

    www.mahopacmassage.com • (845) 628-6286

  • PACKAGE LABEL DISPLAY:

    DR. DONNA RESTIVO DC

    WELLNESS CONSULTANT

    NDC 62185-0024-1

    HOMEOPATHIC

    Brain SUPPORT

    1 FL OZ (30 ml)

    Sleep Tight

  • INGREDIENTS AND APPEARANCE
    SLEEP TIGHT 
    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:62185-0024
    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 (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA10 [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 SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. 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:62185-0024-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/14/2017
    Labeler - Dr. Donna Restivo DC (790796940)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(62185-0024) , api manufacture(62185-0024) , label(62185-0024) , pack(62185-0024)