FDA.reportPublic FDA data

Menopause Plus Mood

Manufacturer
Hyland's Inc. | Merical, Inc
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:51

Label at a glance#

ProductMenopause Plus Mood
Active ingredientCAUSTICUM, BLACK COHOSH, SULFUR, ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, LACHESIS MUTA VENOM, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, VIOLA TRICOLOR, ZINC
Label structure7 sections

Indications and uses

Temporarily relieves the symptoms of moodiness, anxiousness, apprehensiveness, restlessness, nervous tension, fatigue, irritability, hot flashes, and night sweats experienced during menopause.

Dosage and administration

Adults: Take two tablets at onset of symptoms and repeat every four hours as needed.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

Purpose

Belladonna 12X HPUS

hot flashes, night sweats

Caulophyllum 12X HPUS

irritability

Causticum 12X HPUS

anxiousness, apprehensiveness, restlessness

Cimicifuga Racemosa 12X HPUS

hot flashes

Lachesis 30X HPUS

hot flashes

Pulsatilla 12X HPUS

hot flashes, night sweats

Sepia Officinalis 12X HPUS

irritability, hot flashes, night sweats

Sulphur 12X HPUS

hot flashes, night sweats

Viola Tricolor 12X HPUS

nervous tension, fatigue, moodiness

Zincum Metallicum 12X HPUS

apprehensiveness, irritability

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of moodiness, anxiousness, apprehensiveness, restlessness, nervous tension, fatigue, irritability, hot flashes, and night sweats experienced during menopause.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - DO NOT USE SECTION

Do not use: • more than directed. • if you have a known allergy to any ingredient in this product.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper-evident bottle sleeve is broken or missing.

In case of emergency

SPL UNCLASSIFIED SECTION

In case of emergency, contact a medical professional or Poison Control Center immediately. Doctor Wise by Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: Take two tablets at onset of symptoms and repeat every four hours as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

Principal Display Panel - Doctor Wise Menopause+ Mood

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3350-1

DOCTOR

WISE

HOMEOPATHY

MENOPAUSE+

MOOD

Natural relief of

moodiness, irritability,

hot flashes & night sweats*

SOY

FREE

68 SUBLINGUAL TABLETS

INCLUDES TWO 4-TABLET SACHETS

cartoncarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3350-12022-10-20C16284748780-1e4f33bdf-a2b8-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Mood
54973-3350-12022-07-29C16284748780-1e4f33bdf-a2b8-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Mood

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3349MENOPAUSE PLUS MOOD (ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, CAUSTICUM- BLACK COHOSH, LACHESIS MUTA VENOM, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR, VIOLA TRICOLOR AND ZINC) KIT [HYLAND'S INC.]2Legacy NDC20221213_6ad75c70-d9e4-ffc8-e053-2991aa0a6702.zip
54973-3350MENOPAUSE PLUS MOOD (ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, CAUSTICUM- BLACK COHOSH, LACHESIS MUTA VENOM, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR, VIOLA TRICOLOR AND ZINC) KIT [HYLAND'S INC.]2Legacy NDC20221213_6ad75c70-d9e4-ffc8-e053-2991aa0a6702.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-335054973-3350-1
54973-334954973-3349-1, 54973-3349-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CAUSTICUMDD5FO1WKFUACTIB
BLACK COHOSHK73E24S6X9ACTIB
SULFUR70FD1KFU70ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VIOLA TRICOLOR9Q24RAI43VACTIB
ZINCJ41CSQ7QDSACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAUSTICUMDD5FO1WKFUACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VIOLA TRICOLOR9Q24RAI43VACTIB
ZINCJ41CSQ7QDSACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SULFUR70FD1KFU70ACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
413b0160-ce89-1682-e063-6394a90ad6b16ad75c70-d9e4-ffc8-e053-2991aa0a67022025-10-15WarningsExact identifier
spl set id: 6ad75c70-d9e4-ffc8-e053-2991aa0a6702

Reported adverse events (FAERS/openFDA)#

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