GAMMA -12

Manufacturer
Guna spa
Effective date
2022-11-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:34

Label at a glance#

ProductGAMMA -12
Active ingredientINTERFERON GAMMA-1B, INTERLEUKIN-12 HUMAN RECOMBINANT
Label structure10 sections

Indications and uses

For the temporary relief of upper respiratory symptoms due to hay fever or airborne allergies such as: -Cough –Airway irritation –Shortness of breath

Dosage and administration

Take 15 minutes before meals 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

INTERFERON GAMMA    4C    IMMUNE SUPPORT
INTERLEUKIN-12    4C    IMMUNE SUPPORT

USES

OTC - PURPOSE SECTION

For the temporary relief of upper respiratory symptoms due to hay fever or airborne allergies such as: -Cough –Airway irritation –Shortness of breath

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms of cough, shortness of breath, or wheezing do not improve, worsen or persist more than 3 days

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 this and all medicines out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Take 15 minutes before meals

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

INACTIVE INGREDIENT SECTION

inactive ingredient: Ethyl alcohol 30%.

INDICATIONS & USAGE SECTION

take 15 minutes before meals

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of box labelimage of box label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d45267e3-883a-4760-85b5-ebc565c21683Product name120150910

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-405-18GAMMA -1230 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS305
17089-405-18GAMMA -121 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-405GAMMA -12 (INTERLEUKIN-12 HUMAN RECOMBINANT - INTERFERON GAMMA-1B -) SOLUTION/ DROPS [GUNA SPA]5Current NDC, Legacy NDC, 2 package rows20221116_c3366fcd-7d7a-4cf8-995c-798b6d2c9ad1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
INTERFERON GAMMA-1BACTIVE INGREDIENT21K6M2I7AG2
INTERLEUKIN-12 HUMAN RECOMBINANTACTIVE INGREDIENT02FXP10O2U2
INTERFERON GAMMA-1BACTIVE MOIETY21K6M2I7AG2
INTERLEUKIN-12 HUMAN RECOMBINANTACTIVE MOIETY02FXP10O2U2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2

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
17089-40517089-405-18

Ingredients#

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

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

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
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
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 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
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 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
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
GAMMA -12INTERLEUKIN-12 HUMAN RECOMBINANT - INTERFERON GAMMA-1B -Guna spac3366fcd-7d7a-4cf8-995c-798b6d2c9ad12022-11-15WarningsExact identifier
ndc (package): 17089-405-18
ndc (product): 17089-405
ndc11 (package): 17089040518
spl id: ed853c61-ca74-4c3d-e053-2995a90aecb9
spl set id: c3366fcd-7d7a-4cf8-995c-798b6d2c9ad1

Reported adverse events (FAERS/openFDA)#

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