FDA.reportPublic FDA data

Pneumotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-07-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:21:44

Label at a glance#

ProductPneumotox
Active ingredientTRITICUM AESTIVUM WHOLE, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA ROOT, MATRICARIA RECUTITA, ECHINACEA ANGUSTIFOLIA WHOLE, EUCALYPTUS GLOBULUS LEAF, FUCUS VESICULOSUS, HORDEUM VULGARE TOP, IODINE, NASTURTIUM OFFICINALE, PLANTAGO MAJOR, DAIKON, TRIFOLIUM PRATENSE FLOWER, TRIGONELLA FOENUM-GRAECUM WHOLE, SYMPHYTUM OFFICINALE WHOLE, SUS SCROFA LUNG, ORYZA SATIVA WHOLE, SILICON DIOXIDE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZENE, AMMONIUM CHLORIDE, SODIUM LAURYL SULFATE, TURPENTINE OIL, ARSENIC TRIOXIDE, SODIUM CHLORIDE, NITRIC ACID, OENANTHE AQUATICA FRUIT, PHOSPHORIC ACID, PHOSPHORUS, PULSATILLA PRATENSIS WHOLE, TOXICODENDRON PUBESCENS LEAF
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

Triticum Aestivum 1X, 3X Alfalfa 3X, Arnica Montana 3X, Asclepias Tuberosa 3X, Chamomilla 3X, Echinacea (Angustifolia) 3X, Eucalyptus Globulus 3X, Fucus Vesiculosus 3X, Hordeum Vulgare 3X, Iodium 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Symphytum Officinale 6X, Lung (Suis) 8X, Oryza Sativa 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Benzinum 9X, 12X, 15X, 30X, Ammonium Muriaticum 9X, 12X, 15X, 30X, Sodium Lauryl Sulfate 9X, 12X, 15X, 30X, Terebinthina 9X, 12X, 15X, 30X, Arsenicum Album 12X, Natrum Muriaticum 12X, Nitricum Acidum 12X, Phellandrium Aquaticum 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

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.

KEEP OUT OF REACH OF CHILDREN:

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of cough, pressure upon the chest, and cough with expectoration as a consequence of exposure to pollutants.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

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

*For a complete list of Environmental Isodes contact BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional
PNEUMOTOX
HOMEOPATHIC
1 FL OZ (30 ml)

PneumotoxPneumotox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0533-12023-07-12C16284748780-1f386c64a-167f-0266-e053-dadaa90a7c1aDrug Facts:
43857-0533-12023-01-30C16284748780-1f386c64a-167f-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0533-1Pneumotox30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0533PNEUMOTOX (TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20230713_f8846fb1-92e5-4f8e-b3b3-bc620df90a62.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-053343857-0533-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRITICUM AESTIVUM WHOLE3C3Y389JBUACTIB
ALFALFADJO934BRBDACTIB
ARNICA MONTANAO80TY208ZWACTIB
ASCLEPIAS TUBEROSA ROOT1ZL82U5D18ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
HORDEUM VULGARE TOP86507VZR9KACTIB
IODINE9679TC07X4ACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
PLANTAGO MAJORW2469WNO6UACTIB
DAIKON86R5J6D01DACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
TRIGONELLA FOENUM-GRAECUM WHOLE5610HF69OBACTIB
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YACTIB
SUS SCROFA LUNG7GL3G1COB3ACTIB
ORYZA SATIVA WHOLE84IVV0906ZACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ACETONE1364PS73AFACTIB
SODIUM TRIPOLYPHOSPHATE5HK03SA80JACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
BENZENEJ64922108FACTIB
AMMONIUM CHLORIDE01Q9PC255DACTIM
SODIUM LAURYL SULFATE368GB5141JACTIB
TURPENTINE OILC5H0QJ6V7FACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
NITRIC ACID411VRN1TV4ACTIB
OENANTHE AQUATICA FRUITN4LEE4Z93JACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA PRATENSIS WHOLE8E272251DIACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
ndc (package): 43857-0533-1
ndc (product): 43857-0533
ndc11 (package): 43857053301
spl id: 4c238e58-9f3d-4061-beb8-fd1a7107061e
spl set id: f8846fb1-92e5-4f8e-b3b3-bc620df90a62

Reported adverse events (FAERS/openFDA)#

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