FDA.reportPublic FDA data

Combination Remedy 16 - Menopausal Complaints

Manufacturer
Warsan Homoeopathic Laboratories
Effective date
2017-12-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:02

Label at a glance#

ProductCombination Remedy 16 - Menopausal Complaints
Active ingredientSEPIA OFFICINALIS JUICE, GRAPHITE, SANGUINARIA CANADENSIS ROOT, BLACK COHOSH, SULFUR
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

If pregnant or breast-feeding, ask health professional before use.

Do not use if tamper evident seal is missing or broken.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

Cimicifuga Racemosa 30X

Graphites 30X

Sanguinaria Canadensis 30X

Sepia 30X

Sulphur 30X

OTC - PURPOSE SECTION

Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

INACTIVE INGREDIENT SECTION

Purified Water

Alcohol

DOSAGE & ADMINISTRATION SECTION

Adults 18 years and older: Take 10-15 drops in half cup of water 3 times a day.

Not inteded for use by persons under 18.

INDICATIONS & USAGE SECTION

Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

menopausal complaints combo 16.jpgmenopausal complaints combo 16.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69008-4016-12020-01-31C16284748780-19d75b9cf-ebc4-f424-e053-dadaa90a57ce5e4933ab-5e39-cf6d-e053-2a91aa0a89fc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69008-4016-1Combination Remedy 16 - Menopausal Complaints20 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69008-4016COMBINATION REMEDY 16 - MENOPAUSAL COMPLAINTS (CIMICIFUGA RACEMOSA, GRAPHITES, SANGUINARIA CANADENSIS, SEPIA, SULPHUR) SOLUTION/ DROPS [WARSAN HOMOEOPATHIC LABORATORIES]2Legacy NDC, 1 package rows20171225_5e4933ab-5e39-cf6d-e053-2a91aa0a89fc.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69008-401669008-4016-1

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
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
GRAPHITE4QQN74LH4OACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
BLACK COHOSHK73E24S6X9ACTIB
SULFUR70FD1KFU70ACTIB

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
612d55e0-18c1-322b-e053-2991aa0a50085e4933ab-5e39-cf6d-e053-2a91aa0a89fc2017-12-25WarningsExact identifier
spl id: 612d55e0-18c1-322b-e053-2991aa0a5008
spl set id: 5e4933ab-5e39-cf6d-e053-2a91aa0a89fc

Reported adverse events (FAERS/openFDA)#

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