THE FLOWER REMEDY PEACEFUL NIGHT- prunus cerasifera, clematis vitalba, ulmus procera, impatiens glandulifera, quercus robur, helianthemum nummularium, aesculus hippocastanum, ignatia amara liquid

THE FLOWER REMEDY Peaceful Night by

Drug Labeling and Warnings

THE FLOWER REMEDY Peaceful Night by is a Homeopathic medication manufactured, distributed, or labeled by The Flower Remedy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Each 30ml bottle contains equal parts of the active ingredients:
Each 5X (HPUS) Cherry Plum (Prunus cerasifera), Clematis (Clematis vitalba), Elm (Ulmus procera), Impatiens (Impatiens glandulifera), Oak (Quercus robur), Rock Rose (Helianthemum nummularium), White Chestnut (Aesculus hippocastanum), 200C (HPUS) Ignatia Amara

Purpose:

Sleep Aid

USES:

Relief from occasional sleeplessness

DIRECTIONS:

Place 4 drops under the tongue 30-60 minutes before bed and as needed upon undesired awakening from sleep

WARNINGS:

If pregnant or breast feeding, consult a physician before use. Consult a health care provider for children under 12. Consult a physician if symptoms persist for more than 7 days.

Keep out of reach of children.

Inactive ingredients:

water, alcohol

SPL UNCLASSIFIED SECTION

THE FLOWER REMEDY
NATURAL PRODUCTS

Homeopathic Sleep Aid

Homeopathic contains 27% alcohol

*The claims for this product are based upon traditional homeopathic practice, not accepted medical practices. They have not been reviewed by the Food and Drug Administration.

Manufactured and distributed by
The Flower Remedy
2921 Carlisle Blvd NE Suite 209
Albuquerque, NM 87110
(505) 263-7248

Packaging

INGREDIENTS AND APPEARANCE

THE FLOWER REMEDY PEACEFUL NIGHT 
prunus cerasifera, clematis vitalba, ulmus procera, impatiens glandulifera, quercus robur, helianthemum nummularium, aesculus hippocastanum, ignatia amara liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81183-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	5 [hp_X]  in 30 mL
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	5 [hp_X]  in 30 mL
ULMUS MINOR FLOWERING TWIG (UNII: J3O020I532) (ULMUS MINOR FLOWERING TWIG - UNII:J3O020I532)	ULMUS MINOR FLOWERING TWIG	5 [hp_X]  in 30 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [hp_X]  in 30 mL
QUERCUS ROBUR FLOWER (UNII: ML644HED2V) (QUERCUS ROBUR FLOWER - UNII:ML644HED2V)	QUERCUS ROBUR FLOWER	5 [hp_X]  in 30 mL
HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP)	HELIANTHEMUM NUMMULARIUM FLOWER	5 [hp_X]  in 30 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	5 [hp_X]  in 30 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	200 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81183-101-30	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/26/2021

Labeler - The Flower Remedy (117758477)

Establishment
Name	Address	ID/FEI	Business Operations
The Flower Remedy		117758477	manufacture(81183-101)