Label: SLEEP- aesculus hippocastanum, flos, ferrum phos, kali carb, kali phos, mag phos, nat mur, populus termula, flos, prunus cerasifera, flos spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69779-012-01, 69779-012-02 - Packager: Siddha Flower Essences LLC
- 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 January 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
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Purpose
Each dose contains equal parts of:
Aesculus hippocastanum, flos (White Chestnut) 5X HPUS.........can't sleep because of thoughts going around in head
Ferrum Phos 12X HPUS..........................................................restlessness and sleeplessness; anxious dreams
Kali Carb 6C HPUS.................................................................agitated sleep; sleepless after 2 a.m.
Kali Phos 6X HPUS................................................................sleeplessness from excessive mental exertion; worry over business troubles; from nervous exhauston
Mag Phos 12X HPUS.............................................................sleep disturbed by troublesome dreams
Nat Mur 6X HPUS..................................................................drowsiness during day; difficulty falling asleep; agitated sleep
Populus termula, flos (Aspen) 5X HPUS...................................imagination runs wild
Prunus cerasifera, flos (Cherry Plum) 5X HPUS........................feeling blocked or congested inside
The letters HPUS indicate ingredients are in the Homeopathic Pharmacopoeia of the United States. - Uses
- Warnings
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Directions
- spray in mouth at bedtime
- for maximum effect spray in mouth one hour before bed and again at bedtime
- can also be used after waking up in the middle of the night
- use 5 days per week until symptoms are relieved
adults and children 12 years and over
4-5 sprays per dose
children 2 years to under 12 years
2-3 sprays per dose
children under 2 years
consult a doctor
- Other Information
- Inactive Ingredients
- DESCRIPTION
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Side Panel
homeopathy and flower essences:
- Jump start your body's natural ability to heal
- Natural, safe and non-habit forming
- No contraindications. May be effectively used with drugs and other supplements
- Alcohol, sugar, dairy and gluten free
- Prepared in purified water with natural preservatives
- Blends time-tested natural medicine with modern technology
- One month supply
FOUNDATIONAL REMEDIES
may be used with targeted remedies
stress relief
daily alignment
emotional detox
deep-seated stress
TARGETED REMEDIESsleep male virility
healthy hair blood sugar
female balance lung and sinus
muscles and joints throat and voice
youthful skin teeth and gums
happy heart hearing
digestion sight - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SLEEP
aesculus hippocastanum, flos, ferrum phos, kali carb, kali phos, mag phos, nat mur, populus termula, flos, prunus cerasifera, flos sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69779-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER 5 [hp_X] in 29.6 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 29.6 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 6 [hp_C] in 29.6 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X] in 29.6 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 29.6 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 29.6 mL POPULUS TREMULA FLOWERING TOP (UNII: 5Q01F7TPJJ) (POPULUS TREMULA FLOWERING TOP - UNII:5Q01F7TPJJ) POPULUS TREMULA FLOWERING TOP 5 [hp_X] in 29.6 mL PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER 5 [hp_X] in 29.6 mL Inactive Ingredients Ingredient Name Strength TARAXACUM OFFICINALE FLOWERING TOP (UNII: DQS85W46HV) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) LICORICE (UNII: 61ZBX54883) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) WATER (UNII: 059QF0KO0R) SANDALWOOD (UNII: 3641YW25N2) VALERIAN (UNII: JWF5YAW3QW) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69779-012-01 1 in 1 CARTON 04/09/2015 1 29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69779-012-02 1 in 1 CARTON 04/03/2019 2 7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/09/2015 Labeler - Siddha Flower Essences LLC (053674034) Registrant - Siddha Flower Essences LLC (053674034) Establishment Name Address ID/FEI Business Operations Siddha Flower Essences LLC 053674034 manufacture(69779-012)
