SLEEPLESSNESS RELIEF- avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule 
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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Sleeplessness Relief

Active ingredient(s)

Avena sativa 12X

Purpose

sleeplessness, nervousness

Active ingredient(s)

Hepar sulphuris 12X

Purpose

restlessness

Active ingredient(s)

Pulsatilla 15X

Purpose

irregular/agitated sleep

Active ingredient(s)

Zincum valerianicum 12X

Purpose

sleeplessness

Uses:

Relieves symptoms of occasional sleeplessness and/or restless sleep
- Difficulty in going to sleep and frequent waking during the night
- Disturbed sleep due to inability "to switch off", tenseness and restlessness
- Restless, light sleep and excessive dreaming 

Warnings:

- Consult a physician before use if pregnant or breast feeding.
- Consult a physician if symptoms persist for more than 2 weeks or worsen.
- Keep this and all medications out of the reach of children.
- Do not use if tamper-evident seal is broken.
- In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children

Keep this and all medications out of the reach of children

Directions:

For adults and children ages 2 and above:
- Remove tamper-evident seal from neck of bottle.
- Twist cap off bottle.
- Dispense 7-10 globules, place in mouth and allow to dissolve.  Do not swallow globules.
- Allow the globules to dissolve in the mouth.

Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes.  Also take during the night if you wake frequently.

Other information:

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Inactive ingredients:

Calcium carbonate, Xylitol (Sugar-free)

Questions?

Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com

Principal Display Panel

NDC 59262-601-30
Similasan
Sleeplessness Relief
Globules
15g/ 0.529 oz

Sleeplessness Relief Box

Sleeplessness Relief Box

SLEEPLESSNESS RELIEF 
avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-601
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 PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD) ANEMONE PATENS15 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITEScoreno score
ShapeFREEFORMSize1mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59262-601-301078 in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC07/02/2013
Labeler - Similasan Corporation (111566530)

Revised: 7/2013
Document Id: 088190e0-6a24-4b6c-a72a-00bd79ae7895
Set id: 6b94321a-1a0a-4e6e-b931-618df8688eb2
Version: 5
Effective Time: 20130711
 
Similasan Corporation