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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Sleep and Dream

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

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

SLEEP AND DREAM 
anemone pulsatilla, avena sativa flowering top, calcium sulfide and zinc valerate dihydrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP12 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59262-303-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC02/01/2017
Labeler - Similasan Corporation (111566530)

Revised: 12/2016
Document Id: 63e8fc29-515f-4e8a-af82-7c0fdaac2a8b
Set id: 05b23257-8a6e-46ae-90b1-b4b3cb104dfb
Version: 1
Effective Time: 20161212
 
Similasan Corporation