FDA.reportPublic FDA data

PMS Complex

Manufacturer
Nova Homeopathic Therapeutics, Inc.
Effective date
2011-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:40

Label at a glance#

ProductPMS Complex
Active ingredientAPIS MELLIFERA, ATROPINE SULFATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAULOPHYLLUM THALICTROIDES ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, CUPRIC ACETATE, GELSEMIUM SEMPERVIRENS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CHAMAELIRIUM LUTEUM ROOT, STRYCHNOS IGNATII SEED, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, TIN, VIBURNUM OPULUS BARK
Label structure9 sections

Label contents#

Full prescribing information#

Purpose:

OTC - PURPOSE SECTION

Suggested use for one or more of the following symptoms:

Mood swings, mild cramps, bloating, tender breasts, emotional imbalance, lower backache.

Usage and Dosage:

INDICATIONS & USAGE SECTION

For oral use only.

DOSAGE & ADMINISTRATION SECTION

Adults:

    In Acute Phase:
            12-15 drops, every half hour until relief occurs
    When Relief Occurs:
            12-15 drops, 4-6 times per day

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

If symptoms persist, consult a physician.

Do not use if ring on bottom of cap is broken or missing.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica 4X, Atropinum sulphuricum 6X, Calcarea carbonica 12X, Caulophyllum thalictroides 4X, Colocynthis 4X, Cuprum aceticum 4X, Gelsemium sempervirens 4X, Hamamelis virginiana 3X, Helonias Dioica 4X, Ignatia amara 12X, Nux vomica 12X, Pulsatilla 12X, Stannum metalicum 8X, Viburnum opulus 3X

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alcohol, 20% USP

OTC - QUESTIONS SECTION

Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
1-800-225-8094

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PMS Complex Product


PMS Complex ProductPMS Complex Product

PMS Complex Bottle Label


PMS Complex BottlePMS Complex Bottle

PMS Complex Box


PMS Complex BoxPMS Complex Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52731-7020-22019-11-13C16284748780-197449f38-d424-f6ea-e053-dbdaa90aa703PMS Complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52731-7020-1PMS Complex50 mL in 1 BOTTLELIQUID501
52731-7020-2PMS Complex1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52731-7020PMS COMPLEX (APIS MELLIFICA, ATROPINUM SULPHURICUM, CALCAREA CARBONICA, CAULOPHYLLUM THALICTROIDES, COLOCYNTHIS, CUPRUM ACETICUM, GELSEMIUM SEMPERVIRENS, HAMAMELIS VIRGINIANA, HELONIAS DIOICA, IGNATIA AMARA, NUX VOMICA, PULSATILLA, STANNUM METALICUM, VIBURNUM OPULUS) LIQUID [NOVA HOMEOPATHIC THERAPEUTICS, INC.]1Legacy NDC, 2 package rows20120409_6d53dbbe-04d6-40a3-8a2e-64d16f38fdc5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA51
CAULOPHYLLUM THALICTROIDES ROOTACTIVE INGREDIENTJTJ6HH6YEH1
CHAMAELIRIUM LUTEUM ROOTACTIVE INGREDIENTDQV54Y5H3U1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
CUPRIC ACETATEACTIVE INGREDIENT39M11XPH031
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
TINACTIVE INGREDIENT387GMG9FH51
VIBURNUM OPULUS BARKACTIVE INGREDIENTT1UG6H68051
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
CAULOPHYLLUM THALICTROIDES ROOTACTIVE MOIETYJTJ6HH6YEH1
CHAMAELIRIUM LUTEUM ROOTACTIVE MOIETYDQV54Y5H3U1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
SULFATE IONACTIVE MOIETY7IS9N8KPMG1
TINACTIVE MOIETY387GMG9FH51
VIBURNUM OPULUS BARKACTIVE MOIETYT1UG6H68051
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52731-702052731-7020-1, 52731-7020-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
ATROPINE SULFATE03J5ZE7KA5ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CUPRIC ACETATE39M11XPH03ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TIN387GMG9FH5ACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 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
552509d3-3b35-4ea8-ae8a-cdffb8de0c726d53dbbe-04d6-40a3-8a2e-64d16f38fdc52011-06-01WarningsExact identifier
spl id: 552509d3-3b35-4ea8-ae8a-cdffb8de0c72
spl set id: 6d53dbbe-04d6-40a3-8a2e-64d16f38fdc5

Reported adverse events (FAERS/openFDA)#

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