FDA.reportPublic FDA data

GUNA-SPASM

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:10:41

Label at a glance#

ProductGUNA-SPASM
Active ingredientCULTIVATED MUSHROOM, ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, ATROPINE SULFATE, BERBERIS VULGARIS ROOT BARK, METENKEFALIN, CHELIDONIUM MAJUS, COBALT, WATERMELON, GELSEMIUM SEMPERVIRENS ROOT, INTERLEUKIN-10, MAGNESIUM, MELATONIN, SUS SCROFA SYMPATHETIC NERVE, SUS SCROFA VAGUS NERVE
Label structure10 sections

Indications and uses

Temporary relief of: Muscle spasms Colic gas pain

Dosage and administration

Adults and children 12 years and older 20 drops in a little, 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

AGARICUS CAMPESTRIS         4X    ANTISPASTIC
ANTI INTERLEUKIN 1 ALPHA      4C    ANTI-INFLAMMATORY
ATROPINUM SULFURICUM         6X    PAIN RELIEF
BERBERIS VULGARIS         3X    DETOXIFICATION
BETA-ENDORPHIN             4C    PAIN RELIEF
CHELIDONIUM MAJUS         4X    DETOXIFICATION
COBALTUM METALLICUM         4X    ANTISPASTIC
COLOCYNTHIS             4X    BACK SORE
GELSEMIUM              6X     ANALGESIC
INTERLEUKIN 10             4C    ANTI-INFLAMMATORY
MAGNESIUM METALLICUM         4X    ANTISPASTIC
MELATONIN             4C    ANTISPASTIC
SYMPATHETIC NERVE        200X    PAIN RELIEF
VAGAL NERVE            6X    PAIN RELIEF

USES

OTC - PURPOSE SECTION

Temporary relief of:

  • Muscle spasms
  • Colic gas pain

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 this and all medicines out of reach of  children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION



Adults and children 12 years and older 20 drops in a little, 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

5USSPA-Rev05-27-04-185USSPA-Rev05-27-04-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-348-18GUNA-SPASM30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303
17089-348-18GUNA-SPASM1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-348GUNA-SPASM (ATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYMPATHETIC NERVE - SUS SCROFA VAGUS NERVE - WATERMELON - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -) SOLUTION/ DROPS [GUNA SPA]3Current NDC, Legacy NDC, 2 package rows20190103_9d46b4d1-c8e8-40a3-8a32-1cc3d8f602ed.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE INGREDIENTML4QRZ1HCL2
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA52
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U2
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN2
COBALTACTIVE INGREDIENT3G0H8C93622
CULTIVATED MUSHROOMACTIVE INGREDIENT54C8E6W6JY2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q2
INTERLEUKIN-10ACTIVE INGREDIENT9SC4O216V92
MAGNESIUMACTIVE INGREDIENTI38ZP9992A2
MELATONINACTIVE INGREDIENTJL5DK93RCL2
METENKEFALINACTIVE INGREDIENT9JEZ9OD3AS2
SUS SCROFA SYMPATHETIC NERVEACTIVE INGREDIENTH6L0IFR3FE2
SUS SCROFA VAGUS NERVEACTIVE INGREDIENT5AZZ2GHR692
WATERMELONACTIVE INGREDIENT231473QB6R2
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITACTIVE MOIETYML4QRZ1HCL2
ATROPINEACTIVE MOIETY7C0697DR9I2
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U2
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN2
COBALTACTIVE MOIETY3G0H8C93622
CULTIVATED MUSHROOMACTIVE MOIETY54C8E6W6JY2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q2
INTERLEUKIN-10ACTIVE MOIETY9SC4O216V92
MAGNESIUMACTIVE MOIETYI38ZP9992A2
MELATONINACTIVE MOIETYJL5DK93RCL2
METENKEFALINACTIVE MOIETY9JEZ9OD3AS2
SUS SCROFA SYMPATHETIC NERVEACTIVE MOIETYH6L0IFR3FE2
SUS SCROFA VAGUS NERVEACTIVE MOIETY5AZZ2GHR692
WATERMELONACTIVE MOIETY231473QB6R2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2

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
17089-34817089-348-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CULTIVATED MUSHROOM54C8E6W6JYACTIB
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBITML4QRZ1HCLACTIB
ATROPINE SULFATE03J5ZE7KA5ACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
METENKEFALIN9JEZ9OD3ASACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
COBALT3G0H8C9362ACTIB
WATERMELON231473QB6RACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
INTERLEUKIN-109SC4O216V9ACTIB
MAGNESIUMI38ZP9992AACTIB
MELATONINJL5DK93RCLACTIB
SUS SCROFA SYMPATHETIC NERVEH6L0IFR3FEACTIB
SUS SCROFA VAGUS NERVE5AZZ2GHR69ACTIB

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
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact 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
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact 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
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact 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
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 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
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 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

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-SPASMATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYMPATHETIC NERVE - SUS SCROFA VAGUS NERVE - WATERMELON - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa9d46b4d1-c8e8-40a3-8a32-1cc3d8f602ed2018-12-21WarningsExact identifier
ndc (package): 17089-348-18
ndc (product): 17089-348
ndc11 (package): 17089034818
spl id: 7e7d36fb-0ad4-58de-e053-2991aa0a300e
spl set id: 9d46b4d1-c8e8-40a3-8a32-1cc3d8f602ed

Reported adverse events (FAERS/openFDA)#

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