Sleep Aid

Manufacturer
Pro Weight Loss Inc. | Apotheca Company
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:44

Label at a glance#

ProductSleep Aid
Active ingredientADENOSINE 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, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

demineralized water, 25% ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by

Pro Weight Loss Inc., 94 Boylston Cir.

Shrewsbury, MA 01545 • 877-323-0107

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70558-0011-1

Pro Weight Loss

HOMEOPATHIC

Sleep Aid

1 FL OZ (30 ml)

Sleep AidSleep Aid

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70558-0011-1Sleep Aid30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70558-0011SLEEP 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 [PRO WEIGHT LOSS INC.]1Current NDC, Legacy NDC, 1 package rows20210717_d0af311a-e975-4236-8c0e-0418efa7e45f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70558-001170558-0011-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidADENOSINUM 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)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
ndc (package): 70558-0011-1
ndc (product): 70558-0011
ndc11 (package): 70558001101
spl id: 88a30ca1-a920-4b4a-aa8f-2c7e92777efd
spl set id: d0af311a-e975-4236-8c0e-0418efa7e45f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.