Sleep Now Remedy
FDA Label NDC 53852-1016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Living Well Remedies, Llc for the product Sleep Now Remedy (NDC 53852-1016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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.

Indications & Usage

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

Warnings

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

Dosage & 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.

Other Safety Information

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

Inactive Ingredient

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

Otc - Questions

​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

Package Label.Principal Display Panel

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)

* Please review the disclaimer below.