FDA.reportPublic FDA data

GUNA-PMS

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:42

Label at a glance#

ProductGUNA-PMS
Active ingredientARSENIC TRIOXIDE, ESTRADIOL, GOLDENSEAL, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE, MATRICARIA RECUTITA, MELATONIN, PROGESTERONE, STRYCHNOS NUX-VOMICA SEED, SULFUR, SUS SCROFA OVARY, SUS SCROFA PITUITARY GLAND
Label structure10 sections

Indications and uses

Temporary relief of symptoms due to Premenstrual Syndrome such as: Moodiness Cramping Backache

Dosage and administration

Adults: 20 drops in a little water, 2 times per day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ARSENICUM ALBUM 6C MOOD SUPPORT

BETA-ESTRADIOL 6X VAGINAL DRYNESS

CHAMOMILLA 6C CALMING

HYDRASTIS CANADENSIS 6C ANALGESIC

HYPOPHYSIS 8X HORMONAL REGULATION

LACHESIS MUTUS 4C ANXIETY

MAGNESIA PHOSPHORICA 6C METABOLIC SUPPORT

MELATONIN 4C HORMONAL BALANCE

NUX VOMICA 6C MOOD SUPPORT

OOPHORINUM 8X IRREGULAR MENSES

PROGESTERONE 6X IRREGULAR MENSES

SULFUR 6C DETOXIFICATION


USES

OTC - PURPOSE SECTION

Temporary relief of symptoms due to Premenstrual Syndrome such as:

  • Moodiness
  • Cramping
  • Backache

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults: 20 drops in a little water, 2 times per day.

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com, tel. (484) 223-3500

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE SECTION

Take 15 minutes before meals

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyal alcohol 30%.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USPMS-Rev04-03-07-185USPMS-Rev04-03-07-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
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66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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001f367b-fa14-49a0-865b-b395f2553601Product name220190611
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
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85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-290-18GUNA-PMS1 in 1 BOXSOLUTION/ DROPS12
17089-290-18GUNA-PMS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-290GUNA-PMS (ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -) SOLUTION/ DROPS [GUNA SPA]2Current NDC, Legacy NDC, 2 package rows20190104_86f341b1-a8f7-4833-a1be-e51610b05bcd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ESTRADIOLACTIVE INGREDIENT4TI98Z838E1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
MAGNESIUM PHOSPHATEACTIVE INGREDIENT453COF78171
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
MELATONINACTIVE INGREDIENTJL5DK93RCL1
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64Y1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
SULFURACTIVE INGREDIENT70FD1KFU701
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O1
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660T1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HO1
ESTRADIOLACTIVE MOIETY4TI98Z838E1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
MELATONINACTIVE MOIETYJL5DK93RCL1
PROGESTERONEACTIVE MOIETY4G7DS2Q64Y1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
SULFURACTIVE MOIETY70FD1KFU701
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O1
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660T1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-29017089-290-18

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
ALCOHOL3K9958V90MIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
ESTRADIOL4TI98Z838EACTIB
GOLDENSEALZW3Z11D0JVACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE453COF7817ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
MELATONINJL5DK93RCLACTIB
PROGESTERONE4G7DS2Q64YACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SULFUR70FD1KFU70ACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SUS SCROFA PITUITARY GLANDE8S87O660TACTIB

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 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
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
ndc (package): 17089-290-18
ndc (product): 17089-290
ndc11 (package): 17089029018
spl id: 7e9133b3-3360-2bd0-e053-2a91aa0a3bf3
spl set id: 86f341b1-a8f7-4833-a1be-e51610b05bcd

Reported adverse events (FAERS/openFDA)#

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