FDA.reportPublic FDA data

PMS

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:27:27

Label at a glance#

ProductPMS
Active ingredientAPIS MELLIFERA, MATRICARIA CHAMOMILLA WHOLE, BLACK COHOSH, COPPER, STRYCHNOS IGNATII SEED, POTASSIUM IODIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SUS SCROFA OVARY, PLATINUM, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Indications and uses

May temporarily relieves these symptoms associated with PMS: •irregular periods •pain and cramps •backache •fluid retention •mood swings •anxiety and tension •irritability** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults and children over 12:   Spray twice under the tongue three times per day.  For severe symptoms, dosage may be taken up to six times the first day. Children 12 and under:   Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 9.09% of Apis mellifica 200C, Chamomilla 12X, Cimicifuga racemosa 6X, Cuprum metallicum 12X, Ignatia amara 6X, Kali iodatum 200C, Magnesia phosphorica 9X, Oophorinum (suis) 30C, Platinum metallicum 12X, Sepia 9X, Thuja occidentalis 200C.

USES:

OTC - PURPOSE SECTION

May temporarily relieves these symptoms associated with PMS:

•irregular periods
•pain and cramps
•backache
•fluid retention
•mood swings
•anxiety and tension
•irritability**

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

WARNINGS:

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

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

If pregnant or breast feeding, ask a doctor before using product.

OTHER INFORMATION: Store at room temperature.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12:  Spray twice under the tongue three times per day.  For severe symptoms, dosage may be taken up to six times the first day.

Children 12 and under:  Consult a doctor prior to use.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20%v/v, Purified water

USES:

INDICATIONS & USAGE SECTION

May temporarily relieves these symptoms associated with PMS:


•irregular periods
•pain and cramps
•backache
•fluid retention
•mood swings
•anxiety and tension
•irritability**

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

QUESTIONS:

OTC - QUESTIONS SECTION

LIDDELL LABORATORIES

201 APPLE BLVD.

WOODBINE, IA 51579

www.liddell.net

1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS
LIDDELL LABORATORIES
EST. 1994

08PmS

Premenstrual

Syndrome

Relieves PMS symptoms:

irregular periods, pain, cramps,

backache, fluid retention,

mood swings, anxiety,

tension + irritability.

HOMEOPATHIC


DOCTOR FORMULATED
Readily absorbed. Safe.

No known side effects. Easy to use.

1.0 FL OZ (30 ml)

PMS lblPMS lbl

PMS ctnPMS ctn

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
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
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
50845-0109-22024-07-01C16284748780-1ba0f9c33-38ca-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0109-22024-01-30C16284748780-1ba0f9c33-38ca-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0109-22022-04-20C16284748780-1ba0f9c33-38ca-a910-e053-dadaa90a0b85DRUG FACTS:
50845-0109-22021-01-29C16284748780-1ba0f9c33-38ca-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0109-1PMS30 mL in 1 BOTTLE, SPRAYSPRAY309
50845-0109-2PMS1 in 1 CARTONSPRAY19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0109PMS (APIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALIS) SPRAY [LIDDELL LABORATORIES, INC.]9Current NDC, Legacy NDC, 2 package rows20240702_575b4736-5bae-4f15-b55b-3e1fbbb613ff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z3
BLACK COHOSHACTIVE INGREDIENTK73E24S6X93
COPPERACTIVE INGREDIENT789U1901C53
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q3
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ3
PLATINUMACTIVE INGREDIENT49DFR088MY3
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J3
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C23
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K3
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O3
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93973
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z3
BLACK COHOSHACTIVE MOIETYK73E24S6X93
COPPERACTIVE MOIETY789U1901C53
IODIDE IONACTIVE MOIETY09G4I6V86Q3
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8383
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ3
PLATINUMACTIVE MOIETY49DFR088MY3
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C23
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K3
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O3
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93973
ALCOHOLINACTIVE INGREDIENT3K9958V90M3
WATERINACTIVE INGREDIENT059QF0KO0R3

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
50845-010950845-0109-1, 50845-0109-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
COPPER789U1901C5ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
PLATINUM49DFR088MYACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
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 · 45 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii+dosage form
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
45 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
45 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
PMSAPIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.575b4736-5bae-4f15-b55b-3e1fbbb613ff2024-07-01WarningsExact identifier
ndc (package): 50845-0109-2
ndc (package): 50845-0109-1
ndc (product): 50845-0109
ndc11 (package): 50845010901
ndc11 (package): 50845010902
spl id: 60e20997-4f40-4924-b320-cebb1e6128a9
spl set id: 575b4736-5bae-4f15-b55b-3e1fbbb613ff

Reported adverse events (FAERS/openFDA)#

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