FDA.reportPublic FDA data

PNEUMOPLEX

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-03-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:30

Label at a glance#

ProductPNEUMOPLEX
Active ingredientPLANTAGO MAJOR WHOLE, ARSENIC TRIOXIDE, BEEF LUNG, COMFREY ROOT, SILICON DIOXIDE, OENANTHE AQUATICA FRUIT, PHOSPHORUS, SULFUR
Label structure10 sections

Dosage and administration

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

Storage and handling

Store in a cool, dry place.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Plantago Major 3X, Arsenicum Album 6X, Lung (Bovine) 6X, Symphytum Officinale 6X, Silicea 8X, Phellandrium Aquaticum 12X, Phosphorus 12X, Sulphur 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of congestion of the lungs, inflammation of the bronchi, cough with expectoration and hoarseness.

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.

STORAGE:

STORAGE AND HANDLING SECTION

Store in a 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 CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of congestion of the lungs, inflammation of the bronchi, cough with expectoration and hoarseness.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopatchic

PNEUMOPLEX

1 FL OZ (30 mL)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0190-12024-03-26C16284748780-19d75b9d1-1a61-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0190-12020-01-31C16284748780-19d75b9d1-1a61-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0190-1PNEUMOPLEX30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0190PNEUMOPLEX (PLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHUR) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240328_d839aea1-7725-40c1-b000-228843f75b93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BEEF LUNGACTIVE INGREDIENT2I1RTO1MBR1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQ1
OENANTHE AQUATICA FRUITACTIVE INGREDIENTN4LEE4Z93J1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SULFURACTIVE INGREDIENT70FD1KFU701
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BEEF LUNGACTIVE MOIETY2I1RTO1MBR1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQ1
OENANTHE AQUATICA FRUITACTIVE MOIETYN4LEE4Z93J1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
SULFURACTIVE MOIETY70FD1KFU701
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-019043857-0190-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BEEF LUNG2I1RTO1MBRACTIB
COMFREY ROOTM9VVZ08EKQACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
OENANTHE AQUATICA FRUITN4LEE4Z93JACTIB
PHOSPHORUS27YLU75U4WACTIB
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
ndc (package): 43857-0190-1
ndc (product): 43857-0190
ndc11 (package): 43857019001
spl id: 9d960316-e38c-4f18-9233-7e725a62e3d5
spl set id: d839aea1-7725-40c1-b000-228843f75b93

Reported adverse events (FAERS/openFDA)#

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