Menopause

Manufacturer: Foster Regal Laboratories | Dee Cee Laboratories
Effective date: 2012-01-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:49:41

Label at a glance#

ProductMenopause HF

Active ingredientBlack Cohosh, Red Clover, Magnesium Carbonate, Chaste Tree

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cimicifuga racemosa 1X HPUS
Trifolium pratense 1X HPUS
Magnesia carbonica 1X HPUS
Agnus castus 1X HPUS

OTC - PURPOSE SECTION

Relieves hot flashes and
mood changes

Supportive phytoestrogens,
isoflavones for other ingredients

Relieves cramps, nervousness,
and muscle spasms

Improves melancholy and
perimenopausal hormone imbalance

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Uses:Relieves hot flashes, mood changes associated with perimenopausal hormone changes.

WARNINGS SECTION

Warnings

Allergy Alert: Rare allergic reaction to Red clover (Trifolium pratense): includes skin reactions; to Black Cohosh (Cimicfuga racemosa): includes stomach discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions:
Adults take 1 or 2 tablets 3 times daily with meals. An extra
dose may be taken at bedtime if needed. Do not exceed 10
tablets in a 24 hour period. The smallest effective dose should
be used. Do not give to children under 12. Do not exceed
recommended dose.

Other Information:
B-complex vitamins are complementary when used within
the same day as this drug. 1X indicates a 1:9 homeopathic
diluted ingredient. The letters HPUS indicate that these ingre-
dients are officially included in the Homeopathic
Pharmacopeia of the United States. Store at controlled room
temperature 59-86F (15-30 C) Do not use if imprinted
safety seal under cap is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Lactose, vegetable stearic acid, vegetable
cellulose, vegetable magnesium stearate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64175-525-90	2025-08-11	C162847	48780-1	97449f38-bfcf-f6ea-e053-dbdaa90aa703	Menopause-HF
64175-525-90	2019-11-13	C162847	48780-1	97449f38-bfcf-f6ea-e053-dbdaa90aa703	Menopause-HF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64175-525	MENOPAUSE HF (CIMICIFUGA RACEMOSA, TRIFOLIUM PRATENSE, MAGNESIA CARBONICA, AGNUS CASTUS) TABLET [FOSTER REGAL LABORATORIES]	1	Legacy NDC	20120208_cefb6780-75bc-4f52-8b93-ef94f63ca2c1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Black Cohosh	ACTIVE INGREDIENT	K73E24S6X9	1
Chaste Tree	ACTIVE INGREDIENT	433OSF3U8A	1
Magnesium Carbonate	ACTIVE INGREDIENT	0E53J927NA	1
Red Clover	ACTIVE INGREDIENT	L9153EKV2Y	1
Black Cohosh	ACTIVE MOIETY	K73E24S6X9	1
Chaste Tree	ACTIVE MOIETY	433OSF3U8A	1
Magnesium	ACTIVE MOIETY	I38ZP9992A	1
Red Clover	ACTIVE MOIETY	L9153EKV2Y	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Menopause HF
Cimicifuga racemosa, Trifolium pratense, Magnesia carbonica, Agnus castus
Lactose
POWDERED CELLULOSE
MAGNESIUM STEARATE
Black Cohosh
Red Clover
Magnesium Carbonate
Magnesium
Chaste Tree

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64175-525	64175-525-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Lactose	J2B2A4N98G	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
Black Cohosh	K73E24S6X9	ACTIB
Red Clover	L9153EKV2Y	ACTIB
Magnesium Carbonate	0E53J927NA	ACTIB
Chaste Tree	433OSF3U8A	ACTIB

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 · 91 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DISC / EXTRACORPOREAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, EXTENDED RELEASE / ORAL		156 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, FILM COATED / ORAL		392 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DROPS / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	POWDER, FOR SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / SUBLINGUAL	4.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / BUCCAL	4.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	CAPSULE / ORAL		2430 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DISC / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 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
3c1a8113-92b8-96b9-e063-6394a90a2a1a			cefb6780-75bc-4f52-8b93-ef94f63ca2c1	2025-08-11	Warnings	Exact identifier spl set id: cefb6780-75bc-4f52-8b93-ef94f63ca2c1

Reported adverse events (FAERS/openFDA)#

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