Label: SOOTHE AND SLEEP- aesculus hippocastanum, flos, chamomilla, ferr phos, helianthemum nummularium, flos, mimulus guttatus, flos, nat mur, nat phos, nat sulph, phosphorus, verbena officinalis, flos spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 69779-018-01, 69779-018-02 - 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
Each dose contains equal parts of:
Aesculus hippocastanum, flos (White Chestnut) 5X HPUS
Chamomilla 6C HPUS
Ferr Phos 12X HPUS
Helianthemum nummularium, flos (Rock Rose) 5X HPUS
Mimulus guttatus, flos (Mimulus) 5X HPUS
Nat Mur 6X HPUS
Nat Phos 6X HPUS
Nat Sulph 6X HPUS
Phosphorus 6C HPUS
Verbena officinalis, flos (Vervain) 5X HPUS -
Purpose
Each dose contains equal parts of:
Aesculus hippocastanum, flos (White Chestnut) 5X HPUS.........can't sleep enough because thoughts going around in head
Chamomilla 6C HPUS.............................................................restlessness, irritability; cries self to sleep
Ferr Phos 12X HPUS..............................................................restless, sleepless
Helianthemum nummularium, flos (Rock Rose) 5X HPUS...........nerves are weak; overreact and feel helpless
Mimulus guttatus, flos (Mimulus) 5X HPUS...............................anxieties cause inner tension
Nat Mur 6X HPUS...................................................................difficulty falling asleep; nightmares
Nat Phos 6X HPUS................................................................sleepless after excitement; sleepless from 12-3 am
Nat Sulph 6X HPUS................................................................uneasy sleep with anxious dream; tired in the morning
Phosphorus 6C HPUS.............................................................frequent waking; trouble going back to sleep; falls asleep late
Verbena officinalis, flos (Vervain) 5X HPUS...............................children are hyperactive and won't go to bed at night
The letters HPUS indicate ingredients are in the Homeopathic Pharmacopoeia of the United States.
- Uses
- Warnings
-
Directions
- Children 6 years and older 4 sprays in mouth at bedtime
- for maximum effect 4 sprays 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
children 2 years to under 6 years
2 sprays in mouth as needed
children under 2 years
consult a doctor
- may also be applied externally to the top of the child's head
- Other Information
- Inactive Ingredients
- DESCRIPTION
-
Side Panel
flower essences and homeopathy:
- Jump start your child'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
- 5 week supply
siddha kids
stress relief
attention and focus
soothe and sleep
temper tamer
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SOOTHE AND SLEEP
aesculus hippocastanum, flos, chamomilla, ferr phos, helianthemum nummularium, flos, mimulus guttatus, flos, nat mur, nat phos, nat sulph, phosphorus, verbena officinalis, flos sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69779-018 Route of Administration ORAL, TOPICAL 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 MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_C] in 29.6 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 29.6 mL HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER 5 [hp_X] in 29.6 mL MIMULUS GUTTATUS FLOWERING TOP (UNII: 192426I5JU) (MIMULUS GUTTATUS FLOWERING TOP - UNII:192426I5JU) MIMULUS GUTTATUS FLOWERING TOP 5 [hp_X] in 29.6 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 29.6 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X] in 29.6 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 6 [hp_X] in 29.6 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_C] in 29.6 mL VERBENA OFFICINALIS FLOWERING TOP (UNII: 311PNK9CDZ) (VERBENA OFFICINALIS FLOWERING TOP - UNII:311PNK9CDZ) VERBENA OFFICINALIS FLOWERING TOP 5 [hp_X] in 29.6 mL Inactive Ingredients Ingredient Name Strength MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J) LICORICE (UNII: 61ZBX54883) WATER (UNII: 059QF0KO0R) VALERIAN (UNII: JWF5YAW3QW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69779-018-01 1 in 1 CARTON 03/01/2017 1 29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69779-018-02 1 in 1 CARTON 04/03/2017 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 03/01/2017 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(69779-018)
