HOMEOPATHIC SLEEP FORMULA- avena sativa, chamomilla vulgaris, humulus lupulus, passiflora incarnata, coffea cruda, ignatia amara tablet

Homeopathic Sleep Formula by

Drug Labeling and Warnings

Homeopathic Sleep Formula by is a Homeopathic medication manufactured, distributed, or labeled by Indiana Botanic Gardens, ASI Marketing Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PURPOSE

For the relief of occasional sleeplessness and to help you sleep

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 12
years, take 1-2 tablets, dissolve under tongue or
chew 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 a
health professional.

INACTIVE INGREDIENT

Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.

PRINCIPAL DISPLAY PANEL

NDC# 1057802490

Homeopathic Sleep Formula

For the relief of occasional sleeplessness and to help you sleep

300 mg.
90 Tablets

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

SPL UNCLASSIFIED SECTION

FDA Establishment #: 1811575

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

INGREDIENTS AND APPEARANCE

HOMEOPATHIC SLEEP FORMULA 
avena sativa, chamomilla vulgaris, humulus lupulus, passiflora incarnata, coffea cruda, ignatia amara tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-024
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	3 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_C]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	H;367
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-024-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2001

Labeler - Indiana Botanic Gardens (005421771)

Registrant - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	label

Establishment
Name	Address	ID/FEI	Business Operations
ASI Marketing Group		964366611	manufacture