FDA.reportPublic FDA data

Menopause Plus Sleep

Manufacturer
Hyland's | Standard Hoemopathic Company | Merical, Inc
Effective date
2018-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:21

Label at a glance#

ProductMenopause Plus Sleep
Active ingredientNITROGLYCERIN, STRYCHNOS IGNATII SEED, ANEMONE PULSATILLA, BLACK COHOSH, LACHESIS MUTA VENOM, SULFUR, CAULOPHYLLUM THALICTROIDES ROOT, ATROPA BELLADONNA, SEPIA OFFICINALIS JUICE
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

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Belladonna 12X HPUS, Caulophyllum 12X HPUS, Cimicifuga Racemosa 12X HPUS, Glonoinum 12X HPUS, Ignatia Amara 12X HPUS, Lachesis 30X HPUS, Pulsatilla 12X HPUS, Sepia Officinalis 12X HPUS, Sulphur 12X HPUS.

Uses

INDICATIONS & USAGE SECTION

OTC - PURPOSE 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

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 - 60 Sublingual Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCTOR

WISE

HOMEOPATHY

MENOPAUSE+

SLEEP

Natural relief of occasional

sleeplessness, frequent waking,

hot flashes & night sweats

60 SUBLINGUAL TABLETS

labellabel

Label layerLabel layer

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

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

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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

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
d44eaf6e-5a10-fdd6-e053-2995a90a0ea86ab27cd9-c2ab-4893-e053-2a91aa0ad4a32021-12-29WarningsExact identifier
spl set id: 6ab27cd9-c2ab-4893-e053-2a91aa0ad4a3

Reported adverse events (FAERS/openFDA)#

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