FDA.reportPublic FDA data

Menopause Plus Sleep

Manufacturer
Hyland's Inc. | Merical, Inc
Effective date
2022-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:53

Label at a glance#

ProductMenopause Plus Sleep
Active ingredientSTRYCHNOS IGNATII SEED, ATROPA BELLADONNA, SEPIA OFFICINALIS JUICE, SULFUR, ANEMONE PULSATILLA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM
Label structure7 sections

Indications and uses

Temporarily relieves the symptoms of occasional sleeplessness, restlessness, frequent waking, 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

Cimicifuga Racemosa 12X HPUS

hot flashes

Glonoinum 12X HPUS

occasional sleeplessness, restlessness

Ignatia Amara 12X HPUS

frequent waking, occasional sleeplessness, restlessness

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

“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 occasional sleeplessness, restlessness, frequent waking, 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+ Sleep

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3356-1

DOCTOR

WISE

HOMEOPATHY

MENOPAUSE+

SLEEP

Natural relief of occasional

sleeplessness, frequent waking,

hot flashes & night sweats*

SOY

FREE

68 SUBLINGUAL TABLETS

INCLUDES TWO 4-TABLETS SACHETS

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3356-12022-10-20C16284748780-1e4f33bdf-a124-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Sleep
54973-3356-12022-07-29C16284748780-1e4f33bdf-a124-d8a0-e053-dadaa90a6e4eDoctor Wise Menopause+ Sleep

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3355MENOPAUSE PLUS SLEEP (ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, NITROGLYCERIN, STRYCHNOS IGNATII SEED, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR AND LACHESIS MUTA VENOM) KIT [HYLAND'S INC.]2Legacy NDC20221217_6ac64478-7fb8-4cac-e053-2991aa0a9db0.zip
54973-3356MENOPAUSE PLUS SLEEP (ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, BLACK COHOSH, NITROGLYCERIN, STRYCHNOS IGNATII SEED, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SULFUR AND LACHESIS MUTA VENOM) KIT [HYLAND'S INC.]2Legacy NDC20221217_6ac64478-7fb8-4cac-e053-2991aa0a9db0.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-335654973-3356-1
54973-335554973-3355-2, 54973-3355-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
NITROGLYCERING59M7S0WS3ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
ACACIA5C5403N26OIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SULFUR70FD1KFU70ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
BLACK COHOSHK73E24S6X9ACTIB
NITROGLYCERING59M7S0WS3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB

Source Document#

Source XML · Source PDF

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
413b17dc-46fd-7a0b-e063-6294a90a9ea66ac64478-7fb8-4cac-e053-2991aa0a9db02025-10-15WarningsExact identifier
spl set id: 6ac64478-7fb8-4cac-e053-2991aa0a9db0

Reported adverse events (FAERS/openFDA)#

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