NDC 62185-0024 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)

NDC Product Code 62185-0024

NDC CODE: 62185-0024

Proprietary Name: Sleep Tight What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (bach) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Coenzyme Q10 has been used for heart problems (e.g., heart failure, angina), high blood pressure, Parkinson's disease, gum disease, and certain diseases passed down through families (Huntington's disease, muscular dystrophy). It has also been used for reducing the number of migraine headaches and for reducing cell damage that may occur after surgery or treatment with certain anti-cancer drugs. If you have or think you have any of the conditions listed above, consult your doctor for advice on proper care and treatment. Coenzyme Q10 is a substance that your body normally makes. Your body uses it to help keep in good health. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • Melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes (jet lag). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time. Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

NDC Code Structure

  • 62185 - Dr. Donna Restivo Dc

NDC 62185-0024-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Sleep Tight with NDC 62185-0024 is a a human over the counter drug product labeled by Dr. Donna Restivo Dc. The generic name of Sleep Tight is 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). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Dr. Donna Restivo Dc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sleep Tight Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ADENOSINE TRIPHOSPHATE DISODIUM 8 [hp_X]/mL
  • PANTOTHENIC ACID 8 [hp_X]/mL
  • SUS SCROFA PINEAL GLAND 8 [hp_X]/mL
  • LACTIC ACID, L- 8 [hp_X]/mL
  • UBIDECARENONE 8 [hp_X]/mL
  • TRYPTOPHAN 8 [hp_X]/mL
  • MELATONIN 8 [hp_X]/mL
  • PYRROLE 8 [hp_X]/mL
  • ARSENIC TRIOXIDE 10 [hp_X]/mL
  • AVENA SATIVA FLOWERING TOP 10 [hp_X]/mL
  • MATRICARIA CHAMOMILLA 10 [hp_X]/mL
  • ARABICA COFFEE BEAN 10 [hp_X]/mL
  • MERCURIC CHLORIDE 10 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X]/mL
  • SILICON DIOXIDE 10 [hp_X]/mL
  • ZINC VALERATE DIHYDRATE 10 [hp_X]/mL
  • SHIGELLA DYSENTERIAE 30 [hp_C]/mL
  • SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_C]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dr. Donna Restivo Dc
Labeler Code: 62185
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-14-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sleep Tight Product Label Images

Sleep Tight Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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.

Inactive Ingredients:

Demineralized water, 25% ethanol

Questions:

Distributed by Dr. Donna Restivo DC, Wellness Consultant822 South Lake Blvd. Mahopac, New York 10541www.mahopacmassage.com • (845) 628-6286

Package Label Display:

DR. DONNA RESTIVO DCWELLNESS CONSULTANTNDC 62185-0024-1HOMEOPATHICBrain SUPPORT1 FL OZ (30 ml)

* Please review the disclaimer below.