Sleep Now Remedy

Sleep Now Remedy
SPL v1
SPL
SPL Set ID c940517a-1353-421f-a3c2-b49538f7764d
Route
ORAL
Published
Effective Date 2018-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (10 [hp_X]) Camphor (natural) Arabica Coffee Bean Cypripedium Parvifolum Root Strychnos Ignatii Seed Passiflora Incarnata Flowering Top Valerian Aconitum Napellus Horse Chestnut Arsenic Cation (3+) Cinchona Officinalis Bark Hyoscyamus Niger Pulsatilla Vulgaris
Inactive Ingredients
Citric Acid Monohydrate Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-10-08

Description

Active Ingredients: Official HPUS: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 1LM potencies. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

Indications and Usage

Uses: May help to relieve sleeplessness, inability to fall asleep or stay asleep, restless light sleeping, tossing and turning, overactive mind, worry.*

Dosage and Administration

Directions: ​Before bedtime, spray 6 times directly into mouth under your tongue. Take up to 3 additional doses (6 sprays/dose) as needed throughout the night.

Description

Active Ingredients: Official HPUS: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 1LM potencies. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients: Citric acid, potassium sorbate, purified water.

Section 51945-4

LIVING WELL REMEDIES®

​SLEEP NOW

Remedy™

​For relief of sleeplesness,

​inability to fall asleep,

and restless light sleeping

Nature's Homeopathic Medicine

2 fl oz (59.1mL)

Section 53413-1

​Distributed by:

Living Well Remedies, LLC

P.O. Box 704, Franklin Lakes, NJ 07417

For more information visit:

​www.LivingWellRemedies.com

Made in the USA

Section 55105-1

​For relief of sleeplessness,

inability to fall asleep,

and restless light sleeping

Section 55106-9

Active Ingredients: Official HPUS: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

*Claims based on traditional homeopathic practice, not accepted medical evidence.

Not FDA evaluated.

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8

Other Information: Do not use if safety seal is broken or missing. Store at room temperature away from heat and sunlight.


Structured Label Content

Indications and Usage (34067-9)

Uses: May help to relieve sleeplessness, inability to fall asleep or stay asleep, restless light sleeping, tossing and turning, overactive mind, worry.*

Dosage and Administration (34068-7)

Directions: ​Before bedtime, spray 6 times directly into mouth under your tongue. Take up to 3 additional doses (6 sprays/dose) as needed throughout the night.

Warnings and Precautions (34071-1)

Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: Citric acid, potassium sorbate, purified water.

Section 51945-4 (51945-4)

LIVING WELL REMEDIES®

​SLEEP NOW

Remedy™

​For relief of sleeplesness,

​inability to fall asleep,

and restless light sleeping

Nature's Homeopathic Medicine

2 fl oz (59.1mL)

Section 53413-1 (53413-1)

​Distributed by:

Living Well Remedies, LLC

P.O. Box 704, Franklin Lakes, NJ 07417

For more information visit:

​www.LivingWellRemedies.com

Made in the USA

Section 55105-1 (55105-1)

​For relief of sleeplessness,

inability to fall asleep,

and restless light sleeping

Section 55106-9 (55106-9)

Active Ingredients: Official HPUS: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

*Claims based on traditional homeopathic practice, not accepted medical evidence.

Not FDA evaluated.

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8 (60561-8)

Other Information: Do not use if safety seal is broken or missing. Store at room temperature away from heat and sunlight.


Advanced Ingredient Data


Raw Label Data

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