SLEEP AND DREAM- anemone pulsatilla, avena sativa flowering top, calcium sulfide and zinc valerate dihydrate tablet

Sleep and Dream by

Drug Labeling and Warnings

Sleep and Dream by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Sleep & Dream

Drug Facts

Active Ingredients

Avena sativa (Wild Oat) 12X

Purpose

sleeplessness, nervousness

Active Ingredients

Hepar sulphuris calcareum 12X

Purpose

restlessness

Active Ingredients

Pulsatilla (Pasque Flower) 15X

Purpose

irregular or agitated sleep

Active Ingredients

Zincum valerianicum 12X

Purpose

sleeplessness

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

occasional sleeplessness and/or restless, light sleep

difficulty in going to sleep and frequent waking during the night

disturbed sleep due to inability “to switch off”, tenseness and restlessness

Warnings

According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

Consult a physician if symptoms worsen or persist for more than 72 hours.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose get medical help, or contact a Poison Control Center right away.

Directions

For adults and children ages 2 and above:

Take 1-2 tablets 1 hour before bedtime and then again at bedtime or as needed. Tablet may also be dissolved in a glass of water.

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Lactose, Magnesium stearate

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

PRINCIPAL DISPLAY PANEL

NDC: 59262-603-30
Sleep & Dream
Pasque Flower &
Wild Oat Actives
60 Dissolvable Tablets

INGREDIENTS AND APPEARANCE

SLEEP AND DREAM 
anemone pulsatilla, avena sativa flowering top, calcium sulfide and zinc valerate dihydrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-303
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	12 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-303-30	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2017

Labeler - Similasan Corporation (111566530)