FEM Remedy

Manufacturer: Living Well Remedies, LLC
Effective date: 2014-04-16
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:05:49

Label at a glance#

ProductFEM Remedy

Active ingredientAMYL NITRITE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, BLACK COHOSH, IRON, SANGUINARIA CANADENSIS ROOT, SEPIA OFFICINALIS JUICE

Label structure9 sections

Contacts and useful links#

Websitewww.livingwellrenedies.com

www.livingWellRenedies.com

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Spray 3 times directly into mouth under your tongue. Take 3 times daily. Take additional doses as needed during hot flashes and night sweats. Continue until symptoms are relieved.

WARNINGS SECTION

Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

Other: Do not use if safety seal is broken or missing.

OTC - PURPOSE SECTION

Uses: May help to relieve premenopause and menopause symptoms: hot flashes, night sweats, mood swings, low energy, irritability, difficulty sleeping, fatigue, sadness, hair loss, difficulty concentrating.

OTC - ACTIVE INGREDIENT SECTION

Ingredients: Official HPUS:Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia. Equal volumes of each ingredient in 10C, 30C, LM1 potencies.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Bio-Energetically enhanced pure water, citric acid, potassium sorbate.

INDICATIONS & USAGE SECTION

Uses: May help to relieve premenopause and menopause symptoms:

hot flashes
night sweats
mood swings
low energy
irritability
difficulty sleeping
fatigue
sadness
hair loss
difficulty concentrating

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

Distributed by

Living Well Remedies LLC

P.O. Box 704,

Franklin Lakes, NJ 07417

For more information visit:

www.livingWellRenedies.com

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53852-0008-2	2020-01-31	C162847	48780-1	9d75b9d1-2b05-f424-e053-dadaa90a57ce	FEM Remedy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53852-0008-2	FEM Remedy	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53852-0008	FEM REMEDY (AMYL NITROSUM, CALCAREA CARBONICA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, SANGUINARIA CANADENSIS, SEPIA) LIQUID [LIVING WELL REMEDIES, LLC]	2	Legacy NDC, 1 package rows	20140716_2aff35e2-4c66-4b18-89fe-f6c3e2f91cfc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AMYL NITRITE	ACTIVE INGREDIENT	22T8Z09XAK	2
BLACK COHOSH	ACTIVE INGREDIENT	K73E24S6X9	2
IRON	ACTIVE INGREDIENT	E1UOL152H7	2
OYSTER SHELL CALCIUM CARBONATE, CRUDE	ACTIVE INGREDIENT	2E32821G6I	2
SANGUINARIA CANADENSIS ROOT	ACTIVE INGREDIENT	N9288CD508	2
SEPIA OFFICINALIS JUICE	ACTIVE INGREDIENT	QDL83WN8C2	2
AMYL NITRITE	ACTIVE MOIETY	22T8Z09XAK	2
BLACK COHOSH	ACTIVE MOIETY	K73E24S6X9	2
IRON	ACTIVE MOIETY	E1UOL152H7	2
OYSTER SHELL CALCIUM CARBONATE, CRUDE	ACTIVE MOIETY	2E32821G6I	2
SANGUINARIA CANADENSIS ROOT	ACTIVE MOIETY	N9288CD508	2
SEPIA OFFICINALIS JUICE	ACTIVE MOIETY	QDL83WN8C2	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

FEM Remedy
Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia
AMYL NITRITE
OYSTER SHELL CALCIUM CARBONATE, CRUDE
BLACK COHOSH
IRON
SANGUINARIA CANADENSIS ROOT
SEPIA OFFICINALIS JUICE
WATER
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53852-0008	53852-0008-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMYL NITRITE	22T8Z09XAK	ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE	2E32821G6I	ACTIB
BLACK COHOSH	K73E24S6X9	ACTIB
IRON	E1UOL152H7	ACTIB
SANGUINARIA CANADENSIS ROOT	N9288CD508	ACTIB
SEPIA OFFICINALIS JUICE	QDL83WN8C2	ACTIB
WATER	059QF0KO0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 107 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAMUSCULAR	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM, EXTENDED RELEASE / TRANSDERMAL	1.38 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION, CONCENTRATE / INTRAVENOUS	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b46f7bcf-92b0-4293-9368-68203c4d7a31			2aff35e2-4c66-4b18-89fe-f6c3e2f91cfc	2014-04-16	Warnings	Exact identifier spl id: b46f7bcf-92b0-4293-9368-68203c4d7a31 spl set id: 2aff35e2-4c66-4b18-89fe-f6c3e2f91cfc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.