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NDC 81183-0101-30 THE FLOWER REMEDY Peaceful Night 5; 5; 5; 5; 5; 5; 200; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL Details

THE FLOWER REMEDY Peaceful Night 5; 5; 5; 5; 5; 5; 200; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL

THE FLOWER REMEDY Peaceful Night is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Flower Remedy. The primary component is AESCULUS HIPPOCASTANUM FLOWER; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; STRYCHNOS IGNATII SEED; ULMUS MINOR FLOWERING TWIG.

Product Information

NDC	81183-0101
Product ID	81183-101_ba4279e1-3de4-4978-8db6-f42e12661b8a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	THE FLOWER REMEDY Peaceful Night
Proprietary Name Suffix	n/a
Non-Proprietary Name	Prunus cerasifera, Clematis vitalba, Ulmus procera, Impatiens glandulifera, Quercus robur, Helianthemum nummularium, Aesculus hippocastanum, Ignatia Amara
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	5; 5; 5; 5; 5; 5; 200; 5
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL
Substance Name	AESCULUS HIPPOCASTANUM FLOWER; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; STRYCHNOS IGNATII SEED; ULMUS MINOR FLOWERING TWIG
Labeler Name	The Flower Remedy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81183-0101-30 (81183010130)

Pricing Information	N/A
NDC Package Code	81183-101-30
Billing NDC	81183010130
Package	30 mL in 1 BOTTLE, GLASS (81183-101-30)
Marketing Start Date	2021-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0f2b6db-62a4-43b7-88f2-09b2a3c567de Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - The Flower Remedy (117758477)

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

Revised: 4/2021

Document Id: ba4279e1-3de4-4978-8db6-f42e12661b8a

Set id: a0f2b6db-62a4-43b7-88f2-09b2a3c567de

Version: 1

Effective Time: 20210429