FDA.reportPublic FDA data

GUNA-REFLUX

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:10:42

Label at a glance#

ProductGUNA-REFLUX
Active ingredientAETHUSA CYNAPIUM, APOMORPHINE HYDROCHLORIDE, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, SUS SCROFA STOMACH, COLCHICUM AUTUMNALE BULB, WATERMELON, SUS SCROFA ESOPHAGUS, STRYCHNOS IGNATII SEED, IPECAC, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED
Label structure9 sections

Indications and uses

Temporary relief of GERD symptoms such as: Occasional heartburn Acir taste in the mouth Occasional cough at night

Dosage and administration

Adults and children 12 years and older 10 drops in a little water 3 times per day Children between 12 years and 6 years of age 7 drops in a little water 3 times per day Children under 6 years 5 drops in a glass of water 3 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

AETHUSA CYNAPIUM 4X DIGESTIVE

APOMORPHINE HYDROCHLORIDE 6X PAIN RELIEF

BRYONIA ALBA 4X, 10X, 30X, 200X ANTITUSSIVE

CARBO VEGETALIS 12X ANTITUSSIVE

CARDIA VENTRICULI 10X GAS

COLCHICUM AUTUMNALE 6X ANTI-INFLAMMATORY

COLOCYNTHIS 5X, 10X, 30X, 200X NERVOUS IRRITATION RELIEF

ESOPHAGUS 10X DIGESTIVE

IGNATIA AMARA 6X ANTISTRESS

IPECACUANHA 4X ANTITUSSIVE

LYCOPODIUM CLAVATUM 5X, 10X, 30X, 200X DETOXIFICATION

NUX VOMICA 4X, 10X, 30X, 200X ACID REFLUX


USES

OTC - PURPOSE SECTION



Temporary relief of GERD symptoms such as:

  • Occasional heartburn
  • Acir taste in the mouth
  • Occasional cough at night

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION


Adults and children 12 years and older 10 drops in a little water 3 times per day

Children between 12 years and 6 years of age 7 drops in a little water 3 times per day

Children under 6 years 5 drops in a glass of water 3 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

5REF00-REFLUX-REV04-05-11-185REF00-REFLUX-REV04-05-11-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cacec2b-1363-4e94-885c-4189d5e7208aProduct name120251117
d7fea1a2-3459-27e8-1231-1b79988f4937Product name220221207
3a53909e-cbfb-4956-984e-a33101906fd9Product name120201021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-406-18GUNA-REFLUX30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303
17089-406-18GUNA-REFLUX1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-406GUNA-REFLUX (ACTIVATED CHARCOAL - AETHUSA CYNAPIUM - APOMORPHINE HYDROCHLORIDE - BRYONIA ALBA ROOT - COLCHICUM AUTUMNALE BULB - IPECAC - LYCOPODIUM CLAVATUM SPORE - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SEED - WATERMELON - SUS SCROFA STOMACH -) SOLUTION/ DROPS [GUNA SPA]3Current NDC, Legacy NDC, 2 package rows20190104_444c1f4c-dd0c-4525-bb65-c0c211c9487f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H102
AETHUSA CYNAPIUMACTIVE INGREDIENTM6936L953C2
APOMORPHINE HYDROCHLORIDEACTIVE INGREDIENTF39049Y0682
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B2
COLCHICUM AUTUMNALE BULBACTIVE INGREDIENT993QHL78E62
IPECACACTIVE INGREDIENT62I3C8233L2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K2
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139192
SUS SCROFA ESOPHAGUSACTIVE INGREDIENT81FZ7X4MWD2
SUS SCROFA STOMACHACTIVE INGREDIENTT0920P9Z9A2
WATERMELONACTIVE INGREDIENT231473QB6R2
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H102
AETHUSA CYNAPIUMACTIVE MOIETYM6936L953C2
APOMORPHINEACTIVE MOIETYN21FAR7B4S2
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B2
COLCHICUM AUTUMNALE BULBACTIVE MOIETY993QHL78E62
IPECACACTIVE MOIETY62I3C8233L2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K2
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139192
SUS SCROFA ESOPHAGUSACTIVE MOIETY81FZ7X4MWD2
SUS SCROFA STOMACHACTIVE MOIETYT0920P9Z9A2
WATERMELONACTIVE MOIETY231473QB6R2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-40617089-406-18

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
AETHUSA CYNAPIUMM6936L953CACTIB
APOMORPHINE HYDROCHLORIDEF39049Y068ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
SUS SCROFA STOMACHT0920P9Z9AACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
WATERMELON231473QB6RACTIB
SUS SCROFA ESOPHAGUS81FZ7X4MWDACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IPECAC62I3C8233LACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB

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
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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
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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 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 / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact 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
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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
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
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact 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, 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-REFLUXACTIVATED CHARCOAL - AETHUSA CYNAPIUM - APOMORPHINE HYDROCHLORIDE - BRYONIA ALBA ROOT - COLCHICUM AUTUMNALE BULB - IPECAC - LYCOPODIUM CLAVATUM SPORE - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SEED - WATERMELON - SUS SCROFA STOMACH -Guna spa444c1f4c-dd0c-4525-bb65-c0c211c9487f2018-12-21WarningsExact identifier
ndc (package): 17089-406-18
ndc (product): 17089-406
ndc11 (package): 17089040618
spl id: 7e8f7213-7f81-14ab-e053-2991aa0a4669
spl set id: 444c1f4c-dd0c-4525-bb65-c0c211c9487f

Reported adverse events (FAERS/openFDA)#

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