FDA.reportPublic FDA data

STOMAPLEX

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-09-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:58

Label at a glance#

ProductSTOMAPLEX
Active ingredientSILYBUM MARIANUM SEED, GENTIANA LUTEA ROOT, SAMBUCUS NIGRA FLOWERING TOP, SENNA LEAF, TRIPE, ARSENIC TRIOXIDE, ATROPINE SULFATE, ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Carduus Marianus 3X, Gentiana Lutea 3X, Sambucus Nigra 3X, Senna (Cassia Angustifolia) 3X, Stomach (Bovine) 8X, Arsenicum Album 12X, Atropinum Sulphuricum 12X, Carbo Vegetabilis 12X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHLDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of aching in the stomach, nausea, flatulence, fullness in the abdomen, and indigestion.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

STOMAPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

STOMAPLEXSTOMAPLEX

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
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0619-12023-07-21C16284748780-1f386c649-e706-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0619-12023-01-30C16284748780-1f386c649-e706-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0619-1STOMAPLEX30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0619STOMAPLEX (CARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240913_e1b69e9b-ab47-49f4-bd91-89c935533d67.zip

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
43857-061943857-0619-1

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
SILYBUM MARIANUM SEEDU946SH95EEACTIB
GENTIANA LUTEA ROOTS72O3284MSACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
SENNA LEAFAK7JF626KXACTIB
TRIPEC46FS57S0XACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPINE SULFATE03J5ZE7KA5ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
STOMAPLEXCARDUUS MARIANUS, GENTIANA LUTEA, SAMBUCUS NIGRA, SENNA (CASSIA ANGUSTIFOLIA), STOMACH (BOVINE), ARSENICUM ALBUM, ATROPINUM SULPHURICUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.e1b69e9b-ab47-49f4-bd91-89c935533d672024-09-11WarningsExact identifier
ndc (package): 43857-0619-1
ndc (product): 43857-0619
ndc11 (package): 43857061901
spl id: 290e3360-05d6-44e5-a876-a35c05b52cc3
spl set id: e1b69e9b-ab47-49f4-bd91-89c935533d67

Reported adverse events (FAERS/openFDA)#

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