Homeopathic Sleep Formula
FDA Label NDC 10578-024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Indiana Botanic Gardens for the product Homeopathic Sleep Formula (NDC 10578-024). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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

I n g r e d i e n t s :

Oatstraw.............................. 3X HPUS
Chamomile.................... 3X HPUS
Hops......................... 3X HPUS
Passion flower.................... 3X HPUS
Green coffee.............................. 3C HPUS
Ignatius bean............................. 3C HPUS


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

Otc - Purpose

For the relief of occasional sleeplessness and to help you sleep

Otc - Keep Out Of Reach Of Children

KEEP OUT OF
REACH OF CHILDREN.

Indications & Usage

For the relief of occasional sleeplessness and to help you sleep

Warnings

Warning: If you are taking any medications or
are pregnant or breast feeding do not use prior to
consulting a physician.

Dosage & Administration

Suggested Use: Adults and children over 12years, take 1-2 tablets, dissolve under tongue orchew 3 times a day or as directed by a health care professional. Take 15 minutes before or after meals.If symptoms persist for more than 7 days consult ahealth professional.

Inactive Ingredient

Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.

Package Label.Principal Display Panel

NDC# 1057802490

Homeopathic Sleep Formula

For the relief of occasional sleeplessness and to help you sleep

300 mg.
90 Tablets



Image Of Label (Sleep90)

Image Of Label (Sleep90)





User Safety Warnings

For your protection, this container has an outer
safety seal. (Do not accept if missing or broken.)
Best if used by date on bottle. Store in a dry cool place.
Any Questions? 1-800-644-8327
website: www.botanicchoice.com

Other

FDA Establishment #: 1811575

Distributed by: Indiana Botanic Gardens, Inc.
3401 W. 37th Ave. Hobart, IN 46342

* Please review the disclaimer below.