FDA.reportPublic FDA data

GUNA-ANTI IL 1

Manufacturer
Guna spa
Effective date
2022-11-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:33

Label at a glance#

ProductGUNA-ANTI IL 1
Active ingredientANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, CANAKINUMAB
Label structure10 sections

Indications and uses

Temporary relief of: Acute pain Fever

Dosage and administration

Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children under 6 years 5 drops twice a day in a glass of water.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ANTI INTERLEUKIN 1 ALPHA      4C    ACUTE PAIN AND FEVER RELIEF
ANTI INTERLEUKIN 1 BETA        4C     ACUTE PAIN AND FEVER RELIEF

USES

OTC - PURPOSE SECTION

Temporary relief of:

  • Acute pain
  • Fever

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

Keepout of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.

Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.

Children under 6 years 5 drops twice a day in a glass of water.


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

5U1AI1-Guna-Anti_IL_1-Rev2-1007185U1AI1-Guna-Anti_IL_1-Rev2-100718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bd1801bf-1b8e-49c6-894d-a4af5821c1abProduct name120161129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17089-398-182020-03-13C16284748780-19d75b9d0-f08e-f424-e053-dadaa90a57ceGUNA-ANTI IL1
17089-398-182020-01-31C16284748780-19d75b9d0-f08e-f424-e053-dadaa90a57ceGUNA-ANTI IL1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-398-18GUNA-ANTI IL 11 in 1 BOXSOLUTION/ DROPS15
17089-398-18GUNA-ANTI IL 130 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-398GUNA-ANTI IL 1 (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMAB) SOLUTION/ DROPS [GUNA SPA]5Current NDC, Legacy NDC, 2 package rows20221116_aee80c48-6271-48bb-baaa-31427fef1f26.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE INGREDIENTML4QRZ1HCL1
CANAKINUMABACTIVE INGREDIENT37CQ2C7X931
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE MOIETYML4QRZ1HCL1
CANAKINUMABACTIVE MOIETY37CQ2C7X931
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-39817089-398-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITML4QRZ1HCLACTIB
CANAKINUMAB37CQ2C7X93ACTIB

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
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
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 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
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact 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
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 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
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact 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
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 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-ANTI IL 1ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMABGuna spaaee80c48-6271-48bb-baaa-31427fef1f262022-11-15WarningsExact identifier
ndc (package): 17089-398-18
ndc (product): 17089-398
ndc11 (package): 17089039818
spl id: ed853c61-ca6e-4c3d-e053-2995a90aecb9
spl set id: aee80c48-6271-48bb-baaa-31427fef1f26

Reported adverse events (FAERS/openFDA)#

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