FDA.reportPublic FDA data

GUNA-ALLERGY-PREV

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:11:13

Label at a glance#

ProductGUNA-ALLERGY-PREV
Active ingredientAMBROSIA ARTEMISIIFOLIA, ARUNDO PLINIANA ROOT, ASCLEPIAS CURASSAVICA, BLACK CURRANT, CITRIC ACID MONOHYDRATE, HISTAMINE DIHYDROCHLORIDE, INTERFERON GAMMA-1B, HUMAN INTERLEUKIN 12, MANGANESE GLUCONATE, SODIUM PYRUVATE, SODIUM SULFATE, PARIETARIA OFFICINALIS, PHLEUM PRATENSE, ANGUILLA ROSTRATA BLOOD SERUM, SUCCINIC ACID, SULFUR, URTICA URENS, VIBURNUM OPULUS ROOT, WYETHIA HELENIOIDES ROOT
Label structure10 sections

Indications and uses

Temporary relief of allergy symptoms due to exposure to pollen from: Grass Sunflower Nettle

Dosage and administration

For maximum symptom relief start before the anticipated allergen exposure. Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

AMBROSIA ARTEMISIIFOLIA 18X RAGWEED SENSITIVITY

ARUNDO MAURITANICA 18X DETOXIFICATION ACTIVITY

ASCLEPIAS VINCETOXICUM 6X, 10X, 30X IMMUNE SUPPORT

BLACK CURRANT 1X DETOXIFICATION ACTIVITY

CITRICUM ACIDUM 6X ANTIOXIDANT

HISTAMINUM HYDROCHLORICUM 12X, 30X, 200X ANTIHISTAMINE

INTERFERON GAMMA 4C IMMUNE SUPPORT

INTERLEUKIN 12 4C IMMUNE SUPPORT

MANGANESE GLUCONATE 4X IMMUNE SUPPORT

NATRUM PYRUVICUM 6X ANTI-ALLERGY

NATRUM SULF 12X, 30X, 200X METABOLIC SUPPORT

PARIETARIA OFFICINALIS 18X PELLITORY OF THE WALL SENSITIVITY

PHLEUM PRATENSE 18X TIMOTHY SENSITIVITY

SERUM ANGUILLAE 12X, 30X, 200X ANTI-ALLERGY

SUCCINICUM ACIDUM 6X METABOLIC SUPPORT

SULFUR 12X, 30X, 200X SKIN DETOXIFICATION

URTICA URENS 18X NETTLE SENSITIVITY

VIBURNUM OPULUS T LYMPHATIC SYSTEM DETOXIFICATION

WYETHIA HELENIOIDES 18X WYETHIA SENSITIVITY




USES

OTC - PURPOSE SECTION

Temporary relief of allergy symptoms due to exposure to pollen from:

  • Grass
  • Sunflower
  • Nettle

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%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For maximum symptom relief start before the anticipated allergen exposure.


Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

Children under 6 years 5 drops in a glass of water, 2 times per day

QUESTIONS

OTC - QUESTIONS SECTION

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

INDICATIONS & USAGE SECTION


Take 15 minutes before meals

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USPRE-REV04-10-05-185USPRE-REV04-10-05-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d45267e3-883a-4760-85b5-ebc565c21683Product name120150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-299-18GUNA-ALLERGY-PREV30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
17089-299-18GUNA-ALLERGY-PREV1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-299GUNA-ALLERGY-PREV (AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -) SOLUTION/ DROPS [GUNA SPA]2Current NDC, Legacy NDC, 2 package rows20190405_adae93c0-1de9-4e45-ab58-148171f0dc86.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMBROSIA ARTEMISIIFOLIAACTIVE INGREDIENT9W34L2CQ9A1
ANGUILLA ROSTRATA BLOOD SERUMACTIVE INGREDIENTL7B16ESD1U1
ARUNDO PLINIANA ROOTACTIVE INGREDIENTZXE7LB03WC1
ASCLEPIAS CURASSAVICAACTIVE INGREDIENTJSZ93E47EP1
BLACK CURRANTACTIVE INGREDIENT9755T40D111
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QP1
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U1
HUMAN INTERLEUKIN 12ACTIVE INGREDIENT7B590791ER1
INTERFERON GAMMA-1BACTIVE INGREDIENT21K6M2I7AG1
MANGANESE GLUCONATEACTIVE INGREDIENT9YY2F980SV1
PARIETARIA OFFICINALISACTIVE INGREDIENT2C839WQ03N1
PHLEUM PRATENSEACTIVE INGREDIENTS7PW24BX201
SODIUM PYRUVATEACTIVE INGREDIENTPOD38AIF081
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
SUCCINIC ACIDACTIVE INGREDIENTAB6MNQ6J6L1
SULFURACTIVE INGREDIENT70FD1KFU701
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
VIBURNUM OPULUS ROOTACTIVE INGREDIENTT1UG6H68051
WYETHIA HELENIOIDES ROOTACTIVE INGREDIENTJ10PD1AQ0N1
AMBROSIA ARTEMISIIFOLIAACTIVE MOIETY9W34L2CQ9A1
ANGUILLA ROSTRATA BLOOD SERUMACTIVE MOIETYL7B16ESD1U1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
ARUNDO PLINIANA ROOTACTIVE MOIETYZXE7LB03WC1
ASCLEPIAS CURASSAVICAACTIVE MOIETYJSZ93E47EP1
BLACK CURRANTACTIVE MOIETY9755T40D111
HISTAMINEACTIVE MOIETY820484N8I31
HUMAN INTERLEUKIN 12ACTIVE MOIETY7B590791ER1
INTERFERON GAMMA-1BACTIVE MOIETY21K6M2I7AG1
MANGANESE CATION (2+)ACTIVE MOIETYH6EP7W54571
PARIETARIA OFFICINALISACTIVE MOIETY2C839WQ03N1
PHLEUM PRATENSEACTIVE MOIETYS7PW24BX201
PYRUVIC ACIDACTIVE MOIETY8558G7RUTR1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
SUCCINIC ACIDACTIVE MOIETYAB6MNQ6J6L1
SULFURACTIVE MOIETY70FD1KFU701
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
VIBURNUM OPULUS ROOTACTIVE MOIETYT1UG6H68051
WYETHIA HELENIOIDES ROOTACTIVE MOIETYJ10PD1AQ0N1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-29917089-299-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
ARUNDO PLINIANA ROOTZXE7LB03WCACTIB
ASCLEPIAS CURASSAVICAJSZ93E47EPACTIB
BLACK CURRANT9755T40D11ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
INTERFERON GAMMA-1B21K6M2I7AGACTIB
HUMAN INTERLEUKIN 127B590791ERACTIB
MANGANESE GLUCONATE9YY2F980SVACTIB
SODIUM PYRUVATEPOD38AIF08ACTIB
SODIUM SULFATE0YPR65R21JACTIB
PARIETARIA OFFICINALIS2C839WQ03NACTIB
PHLEUM PRATENSES7PW24BX20ACTIB
ANGUILLA ROSTRATA BLOOD SERUML7B16ESD1UACTIB
SUCCINIC ACIDAB6MNQ6J6LACTIB
SULFUR70FD1KFU70ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
VIBURNUM OPULUS ROOTT1UG6H6805ACTIB
WYETHIA HELENIOIDES ROOTJ10PD1AQ0NACTIB

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
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 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
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 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-ALLERGY-PREVAMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -Guna spaadae93c0-1de9-4e45-ab58-148171f0dc862018-12-21WarningsExact identifier
ndc (package): 17089-299-18
ndc (product): 17089-299
ndc11 (package): 17089029918
spl id: 7e029048-a7aa-68a5-e053-2a91aa0af0be
spl set id: adae93c0-1de9-4e45-ab58-148171f0dc86

Reported adverse events (FAERS/openFDA)#

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