Sleep Aid: Homeopathic Product Information

SLEEP AID- adenosine triphosphate disodium, pantothenic acid, sus scrofa pineal gland, lactic acid, l-, ubidecarenone, tryptophan, melatonin, pyrrole, arsenic trioxide, avena sativa flowering top, matricaria chamomilla whole, arabica coffee bean, mercuric chloride, passiflora incarnata flowering top, silicon dioxide, zinc valerate dihydrate, shigella dysenteriae and salmonella enterica enterica serovar enteritidis liquid
Pro Weight Loss Inc.

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.

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
(click image for full-size original)
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 Type HUMAN OTC DRUG Item Code (Source) NDC:70558-0011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE TRIPHOSPHATE DISODIUM (ADENOSINE TRIPHOSPHATE) ADENOSINE TRIPHOSPHATE DISODIUM 8 [hp_X] in 1 mL
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 8 [hp_X] in 1 mL
SUS SCROFA PINEAL GLAND (SUS SCROFA PINEAL GLAND) SUS SCROFA PINEAL GLAND 8 [hp_X] in 1 mL
LACTIC ACID, L- (LACTIC ACID, L-) LACTIC ACID, L- 8 [hp_X] in 1 mL
UBIDECARENONE (UBIDECARENONE) UBIDECARENONE 8 [hp_X] in 1 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 8 [hp_X] in 1 mL
MELATONIN (MELATONIN) MELATONIN 8 [hp_X] in 1 mL
PYRROLE (PYRROLE) PYRROLE 8 [hp_X] in 1 mL
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 10 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 10 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA WHOLE (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA WHOLE 10 [hp_X] in 1 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 10 [hp_X] in 1 mL
MERCURIC CHLORIDE (MERCURIC CATION) MERCURIC CHLORIDE 10 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 10 [hp_X] in 1 mL
ZINC VALERATE DIHYDRATE (VALERIC ACID) ZINC VALERATE DIHYDRATE 10 [hp_X] in 1 mL
SHIGELLA DYSENTERIAE (SHIGELLA DYSENTERIAE) SHIGELLA DYSENTERIAE 30 [hp_C] in 1 mL
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS (SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS) SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS 30 [hp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70558-0011-1 30 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/16/2021
Labeler — Pro Weight Loss Inc. (080166665)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (70558-0011), api manufacture (70558-0011), label (70558-0011), pack (70558-0011)

Revised: 07/2021 Pro Weight Loss Inc.

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