FDA.reportPublic FDA data

PMS

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:33:07

Label at a glance#

ProductPMS
Active ingredientANGELICA ARCHANGELICA ROOT, BLACK COHOSH, FUCUS VESICULOSUS, SUS SCROFA HYPOTHALAMUS, MAGNESIUM GLUCONATE, SUS SCROFA OVARY, PYRIDOXINE HYDROCHLORIDE, LYCOPERDON UTRIFORME FRUITING BODY, COPPER, SEPIA OFFICINALIS JUICE, ZINC, LACHESIS MUTA VENOM
Label structure9 sections

Indications and uses

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

Dosage and administration

• 10 drops orally, 3 times a day. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Angelica Archangelica 3X, Bovista 12X, Cimicifuga Racemosa 3X, Cuprum Metallicum 12X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Lachesis Mutus 15X, Magnesium Gluconicum Dihydricum 6X, Oophorinum 6X, Pyridoxinum Hydrochloricum 6X, Sepia 12X, Zincum Metallicum 12X.

PURPOSE:

OTC - PURPOSE SECTION

Angelica Archangelica - nausea,** Bovista - itching,** Cimicifuga Racemosa – minor backpains,** Cuprum Metallicum - cramps,** Fucus Vesiculosus - headache,** Hypothalamus Suis - fatigue,** Lachesis Mutus - headache,** Magnesium Gluconicum Dihydricum – low energy,** Oophorinum – hot flashes,** Pyridoxinum Hydrochloricum - antioxidant,** Sepia – irregular menstrual cycles,** Zincum Metallicum – tiredness**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

WARNINGS:

WARNINGS SECTION

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

PMS

HOMEOPATHIC

1 FL OZ (30 ml)

PMSPMS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0314-12024-09-03C16284748780-1ba0f9c33-10cf-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0314-12021-01-29C16284748780-1ba0f9c33-10cf-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0314-1PMS30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0314PMS (ANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, HYPOTHALAMUS SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, OOPHORINUM (SUIS) PYRIDOXINUM HYDROCHLORICUM, BOVISTA, CUPRUM METALLICUM, SEPIA, ZINCUM METALLICUM, LACHESIS MUTUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]5Current NDC, Legacy NDC, 1 package rows20250406_85304d4f-78b9-499e-8e1d-9202d9cde33d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANGELICA ARCHANGELICA ROOTACTIVE INGREDIENTDTN01M69SN1
BLACK COHOSHACTIVE INGREDIENTK73E24S6X91
COPPERACTIVE INGREDIENT789U1901C51
FUCUS VESICULOSUSACTIVE INGREDIENT535G2ABX9M1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
LYCOPERDON UTRIFORME FRUITING BODYACTIVE INGREDIENTK2A74U428F1
MAGNESIUM GLUCONATEACTIVE INGREDIENTT42NAD2KHC1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SUS SCROFA HYPOTHALAMUSACTIVE INGREDIENTN6R0856Z791
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O1
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
ANGELICA ARCHANGELICA ROOTACTIVE MOIETYDTN01M69SN1
BLACK COHOSHACTIVE MOIETYK73E24S6X91
COPPERACTIVE MOIETY789U1901C51
FUCUS VESICULOSUSACTIVE MOIETY535G2ABX9M1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
LYCOPERDON UTRIFORME FRUITING BODYACTIVE MOIETYK2A74U428F1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SUS SCROFA HYPOTHALAMUSACTIVE MOIETYN6R0856Z791
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O1
ZINCACTIVE MOIETYJ41CSQ7QDS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-031443857-0314-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANGELICA ARCHANGELICA ROOTDTN01M69SNACTIB
BLACK COHOSHK73E24S6X9ACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
SUS SCROFA HYPOTHALAMUSN6R0856Z79ACTIB
MAGNESIUM GLUCONATET42NAD2KHCACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
LYCOPERDON UTRIFORME FRUITING BODYK2A74U428FACTIB
COPPER789U1901C5ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
ZINCJ41CSQ7QDSACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PMSANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, HYPOTHALAMUS SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, OOPHORINUM (SUIS) PYRIDOXINUM HYDROCHLORICUM, BOVISTA, CUPRUM METALLICUM, SEPIA, ZINCUM METALLICUM, LACHESIS MUTUSBioActive Nutritional, Inc.85304d4f-78b9-499e-8e1d-9202d9cde33d2025-04-02WarningsExact identifier
ndc (package): 43857-0314-1
ndc (product): 43857-0314
ndc11 (package): 43857031401
spl id: a95c2a6d-b962-43bd-84b0-d9f8812364f4
spl set id: 85304d4f-78b9-499e-8e1d-9202d9cde33d

Reported adverse events (FAERS/openFDA)#

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