Search by Drug Name or NDC

NDC 62185-0024-01 Sleep Tight 8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Sleep Tight 8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Sleep Tight is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Donna Restivo DC. The primary component is ADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; LACTIC ACID, L-; MATRICARIA CHAMOMILLA; MELATONIN; MERCURIC CHLORIDE; PANTOTHENIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SU.

Product Information

NDC	62185-0024
Product ID	62185-0024_38479502-2c50-4161-ac06-ba7e7ddf5ad3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sleep Tight
Proprietary Name Suffix	n/a
Non-Proprietary Name	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, Silice
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; LACTIC ACID, L-; MATRICARIA CHAMOMILLA; MELATONIN; MERCURIC CHLORIDE; PANTOTHENIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SU
Labeler Name	Dr. Donna Restivo DC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 62185-0024-01 (62185002401)

Pricing Information	N/A
NDC Package Code	62185-0024-1
Billing NDC	62185002401
Package	30 mL in 1 BOTTLE, DROPPER (62185-0024-1)
Marketing Start Date	2017-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5955fbc-71f8-4fe0-9df0-42f337ab9c7d Details

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)

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62185-0024
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE DISODIUM	8 [hp_X] in 1 mL
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	8 [hp_X] in 1 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	8 [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)	UBIDECARENONE	8 [hp_X] in 1 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX)	TRYPTOPHAN	8 [hp_X] in 1 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	8 [hp_X] in 1 mL
PYRROLE (UNII: 86S1ZD6L2C) (PYRROLE - UNII:86S1ZD6L2C)	PYRROLE	8 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	10 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X] in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	10 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	10 [hp_X] in 1 mL
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	10 [hp_X] in 1 mL
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J)	SHIGELLA DYSENTERIAE	30 [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 ENTERITIDIS	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62185-0024-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/14/2017

Labeler - Dr. Donna Restivo DC (790796940)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(62185-0024) , api manufacture(62185-0024) , label(62185-0024) , pack(62185-0024)

Revised: 1/2022

Document Id: 38479502-2c50-4161-ac06-ba7e7ddf5ad3

Set id: b5955fbc-71f8-4fe0-9df0-42f337ab9c7d

Version: 3

Effective Time: 20220117

Search by Drug Name or NDC

NDC 62185-0024-01 Sleep Tight 8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Sleep Tight 8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 62185-0024-01 (62185002401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b5955fbc-71f8-4fe0-9df0-42f337ab9c7d Details

ACTIVE INGREDIENTS:

HOMEOPATHIC INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

HOMEOPATHIC INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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