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

Sleeplessness Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SLEEPLESSNESS RELIEF 
avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59262-601
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 PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD)	ANEMONE PATENS	15 [hp_X]
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score	no score
Shape	FREEFORM	Size	1mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59262-601-30	1078 in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		07/02/2013

Labeler - Similasan Corporation (111566530)