Label: SLEEPLESSNESS RELIEF- avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule
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Contains inactivated NDC Code(s)
NDC Code(s): 59262-601-30 - Packager: Similasan Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated July 11, 2013
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- Active ingredient(s)
- Purpose
- Active ingredient(s)
- Purpose
- Active ingredient(s)
- Purpose
- Active ingredient(s)
- Purpose
- Uses:
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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. -
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:
- Inactive ingredients:
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INGREDIENTS AND APPEARANCE
SLEEPLESSNESS RELIEF
avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globuleProduct 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)