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NDC 81183-0103-30 THE FLOWER REMEDY Happy Heart 5; 5; 5; 5; 5; 5; 5; 200; 200; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL Details

THE FLOWER REMEDY Happy Heart 5; 5; 5; 5; 5; 5; 5; 200; 200; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL

THE FLOWER REMEDY Happy Heart is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Flower Remedy. The primary component is CASTANEA SATIVA FLOWER; GENTIANELLA AMARELLA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; ORNITHOGALUM UMBELLATUM FLOWERING TOP; SALIX ALBA FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CHLORIDE; STRYCHNOS IG.

Product Information

NDC	81183-0103
Product ID	81183-103_2ebde8f9-61a3-4346-8d5e-6237828774d9
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 Happy Heart
Proprietary Name Suffix	n/a
Non-Proprietary Name	Gentianella amarella, Ulex europaeus, Ilex aquifolium, Lonicera caprifolium, Sinapis arvensis, Ornithogalum umbellatum, Castanea sativa, Salix vitellina, Ignatia Amara, Natrum Muriaticum
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	5; 5; 5; 5; 5; 5; 5; 200; 200; 5
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL
Substance Name	CASTANEA SATIVA FLOWER; GENTIANELLA AMARELLA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; ORNITHOGALUM UMBELLATUM FLOWERING TOP; SALIX ALBA FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CHLORIDE; STRYCHNOS IG
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 81183-0103-30 (81183010330)

Pricing Information	N/A
NDC Package Code	81183-103-30
Billing NDC	81183010330
Package	30 mL in 1 BOTTLE, GLASS (81183-103-30)
Marketing Start Date	2021-04-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6decd8fe-7593-4421-926c-f92400240032 Details

Active Ingredients:

Each 30 ml bottle contains equal parts of the active ingredients:

Each 5X (HPUS) Gentian (Gentianella amarella), Gorse (Ulex europaeus), Holly (Ilex aquifolium), Honeysuckle (Lonicera caprifolium), Mustard (Sinapis arvensis), Star of Bethlehem (Ornithogalum umbellatum), Sweet Chestnut (Castanea sativa), Willow (Salix vitellina). 200C (HPUS) Ignatia Amara, 200C (HPUS) Natrum Muriaticum

Purpose:

Mood Support

USES:

for the relief of occasional, situational sadness

DIRECTIONS:

Take 4 drops under the tongue or in water 4 times daily.

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 Mood Support

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 HAPPY HEART

gentianella amarella, ulex europaeus, ilex aquifolium, lonicera caprifolium, sinapis arvensis, ornithogalum umbellatum, castanea sativa, salix vitellina, ignatia amara, natrum muriaticum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81183-103
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GENTIANELLA AMARELLA FLOWER (UNII: ZKH2SOY1AR) (GENTIANELLA AMARELLA FLOWER - UNII:ZKH2SOY1AR)	GENTIANELLA AMARELLA FLOWER	5 [hp_X] in 30 mL
ULEX EUROPAEUS FLOWER (UNII: 398DBS1PXN) (ULEX EUROPAEUS FLOWER - UNII:398DBS1PXN)	ULEX EUROPAEUS FLOWER	5 [hp_X] in 30 mL
ILEX AQUIFOLIUM FLOWERING TOP (UNII: 5ENR9SAN1W) (ILEX AQUIFOLIUM FLOWERING TOP - UNII:5ENR9SAN1W)	ILEX AQUIFOLIUM FLOWERING TOP	5 [hp_X] in 30 mL
LONICERA CAPRIFOLIUM FLOWERING TOP (UNII: 1X0T378SXY) (LONICERA CAPRIFOLIUM FLOWERING TOP - UNII:1X0T378SXY)	LONICERA CAPRIFOLIUM FLOWERING TOP	5 [hp_X] in 30 mL
SINAPIS ARVENSIS FLOWERING/FRUITING TOP (UNII: WWX61E1ZAK) (SINAPIS ARVENSIS FLOWERING/FRUITING TOP - UNII:WWX61E1ZAK)	SINAPIS ARVENSIS FLOWERING/FRUITING TOP	5 [hp_X] in 30 mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B)	ORNITHOGALUM UMBELLATUM FLOWERING TOP	5 [hp_X] in 30 mL
CASTANEA SATIVA FLOWER (UNII: YHZ719F7M3) (CASTANEA SATIVA FLOWER - UNII:YHZ719F7M3)	CASTANEA SATIVA FLOWER	5 [hp_X] in 30 mL
SALIX ALBA FLOWERING TOP (UNII: XBP5X7E70R) (SALIX ALBA FLOWERING TOP - UNII:XBP5X7E70R)	SALIX ALBA FLOWERING TOP	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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	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:81183-103-30	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(81183-103)

Revised: 5/2021

Document Id: 2ebde8f9-61a3-4346-8d5e-6237828774d9

Set id: 6decd8fe-7593-4421-926c-f92400240032

Version: 1

Effective Time: 20210531