PNEUMOTOX- triticum aestivum, alfalfa, arnica montana, asclepias tuberosa, chamomilla, echinacea, eucalyptus globulus, fucus vesiculosus, hordeum vulgare, laminaria digitata, nasturtium aquaticum, plantago major, raphanus sativus, symphytum officinale, trifolium pratense, trigonella foenum-graecum, oryza sativa, lung (suis), silicea, acetone, sodium tripolyphosphate, propylene glycol, sodium benzene sulfonate, ammonium muriaticum, sodium lauryl sulfate, terebinthina, arsenicum album, natrum muriaticum, liquid 
BioActive Nutritional

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

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, Laminaria Digitata 3X, Nasturtium Aquaticum 3X, Plantago Major 3X, Raphanus Sativus 3X, Symphytum Officinale 3X, Trifolium Pratense 3X, Trigonella Foenum-Graecum 3X, Oryza Sativa 8X, Lung (Suis) 8X, Silicea 8X, Acetone 9X, 12X, 15X, 30X, Sodium Tripolyphosphate 9X, 12X, 15X, 30X, Propylene Glycol 9X, 12X, 15X, 30X, Sodium Benzene Sulfonate 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 (Vulgaris) 12X, Rhus Tox 12X, Paraffinum 30X, 60X, 200X, Ethylene Glycol 30X, 60X, 200X, Hexadecanoic Acid 30X, 60X, 200X, Dimethicone 30X, 60X, 200X, Poly Acrylic Acid 30X, 60X, 200X, Glutaraldehyde 30X, 60X, 200X, Methacrylates 30X, 60X, 200X, Citricum Acidum 30X, 60X, 200X, Tartaricum Acidum 30X, 60X, 200X, Anthraquinone 30X, 60X, 200X, Hydrogen Peroxide 30X, 60X, 200X, Glycolic Acid 30X, 60X, 200X, Ammoinium Thioglycolate 30X, 60X, 200X, Natrum Carbonicum 30X, 60X, 200X, Ethanolamine 30X, 60X, 200X, 2,5 Diaminotoluene (Sulfate) 30X, 60X, 200X, 4 Amino Phenol 30X, 60X, 200X.

INDICATIONS:

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

WARNINGS:

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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

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

INDICATIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

PNEUMOTOX

1fl oz (30 ml)

Pneumotox

PNEUMOTOX 
triticum aestivum, alfalfa, arnica montana, asclepias tuberosa, chamomilla, echinacea, eucalyptus globulus, fucus vesiculosus, hordeum vulgare, laminaria digitata, nasturtium aquaticum, plantago major, raphanus sativus, symphytum officinale, trifolium pratense, trigonella foenum-graecum, oryza sativa, lung (suis), silicea, acetone, sodium tripolyphosphate, propylene glycol, sodium benzene sulfonate, ammonium muriaticum, sodium lauryl sulfate, terebinthina, arsenicum album, natrum muriaticum, liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA3 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
ASCLEPIAS TUBEROSA FLOWERING TOP (UNII: Y62M9GTW4A) (ASCLEPIAS TUBEROSA FLOWERING TOP - UNII:Y62M9GTW4A) ASCLEPIAS TUBEROSA FLOWERING TOP3 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF3 [hp_X]  in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS3 [hp_X]  in 1 mL
HORDEUM VULGARE TOP (UNII: 86507VZR9K) (HORDEUM VULGARE TOP - UNII:86507VZR9K) HORDEUM VULGARE TOP3 [hp_X]  in 1 mL
LAMINARIA DIGITATA (UNII: 15E7C67EE8) (LAMINARIA DIGITATA - UNII:15E7C67EE8) LAMINARIA DIGITATA3 [hp_X]  in 1 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM OFFICINALE - UNII:YH89GMV676) NASTURTIUM OFFICINALE3 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR3 [hp_X]  in 1 mL
RAPHANUS SATIVUS (UNII: 86R5J6D01D) (DAIKON - UNII:86R5J6D01D) RAPHANUS SATIVUS3 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT3 [hp_X]  in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
FENUGREEK SEED (UNII: 654825W09Z) (FENUGREEK SEED - UNII:654825W09Z) FENUGREEK SEED3 [hp_X]  in 1 mL
BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG) BROWN RICE8 [hp_X]  in 1 mL
SUS SCROFA LUNG (UNII: 7GL3G1COB3) (SUS SCROFA LUNG - UNII:7GL3G1COB3) SUS SCROFA LUNG8 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE8 [hp_X]  in 1 mL
ACETONE (UNII: 1364PS73AF) (ACETONE - UNII:1364PS73AF) ACETONE9 [hp_X]  in 1 mL
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J) (TRIPOLYPHOSPHATE ION - UNII:5798IYA5AY) SODIUM TRIPOLYPHOSPHATE9 [hp_X]  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL9 [hp_X]  in 1 mL
SODIUM BENZENESULFONATE (UNII: K5RM14AZHX) (BENZENESULFONIC ACID - UNII:685928Z18A) SODIUM BENZENESULFONATE9 [hp_X]  in 1 mL
AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CATION9 [hp_X]  in 1 mL
SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154) SODIUM LAURYL SULFATE9 [hp_X]  in 1 mL
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F) TURPENTINE OIL9 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID12 [hp_X]  in 1 mL
OENANTHE AQUATICA FRUIT (UNII: N4LEE4Z93J) (OENANTHE AQUATICA FRUIT - UNII:N4LEE4Z93J) OENANTHE AQUATICA FRUIT12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 mL
PARAFFIN (UNII: I9O0E3H2ZE) (PARAFFIN - UNII:I9O0E3H2ZE) PARAFFIN30 [hp_X]  in 1 mL
ETHYLENE GLYCOL (UNII: FC72KVT52F) (ETHYLENE GLYCOL - UNII:FC72KVT52F) ETHYLENE GLYCOL30 [hp_X]  in 1 mL
PROPYL ALCOHOL (UNII: 96F264O9SV) (PROPYL ALCOHOL - UNII:96F264O9SV) PROPYL ALCOHOL30 [hp_X]  in 1 mL
PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1) PALMITIC ACID30 [hp_X]  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 [hp_X]  in 1 mL
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) (POLYACRYLIC ACID (8000 MW) - UNII:73861X4K5F) SODIUM POLYACRYLATE (8000 MW)30 [hp_X]  in 1 mL
GLUTARAL (UNII: T3C89M417N) (GLUTARAL - UNII:T3C89M417N) GLUTARAL30 [hp_X]  in 1 mL
METHYL METHACRYLATE (UNII: 196OC77688) (METHYL METHACRYLATE - UNII:196OC77688) METHYL METHACRYLATE30 [hp_X]  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID30 [hp_X]  in 1 mL
TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H) TARTARIC ACID30 [hp_X]  in 1 mL
ANTHRAQUINONE (UNII: 030MS0JBDO) (ANTHRAQUINONE - UNII:030MS0JBDO) ANTHRAQUINONE30 [hp_X]  in 1 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 [hp_X]  in 1 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID30 [hp_X]  in 1 mL
AMMONIUM THIOGLYCOLATE (UNII: 6P9E788VZZ) (AMMONIUM THIOGLYCOLATE - UNII:6P9E788VZZ) AMMONIUM THIOGLYCOLATE30 [hp_X]  in 1 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE30 [hp_X]  in 1 mL
MONOETHANOLAMINE (UNII: 5KV86114PT) (MONOETHANOLAMINE - UNII:5KV86114PT) MONOETHANOLAMINE30 [hp_X]  in 1 mL
2,5-DIAMINOTOLUENE SULFATE (UNII: 8PSD05SPE2) (TOLUENE-2,5-DIAMINE - UNII:24JO8Z0RJU) 2,5-DIAMINOTOLUENE SULFATE30 [hp_X]  in 1 mL
P-AMINOPHENOL (UNII: R7P8FRP05V) (P-AMINOPHENOL - UNII:R7P8FRP05V) P-AMINOPHENOL30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0357-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/29/201502/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/29/201502/24/2020
Labeler - BioActive Nutritional (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0357) , api manufacture(43857-0357) , label(43857-0357) , pack(43857-0357)

Revised: 9/2016
Document Id: 54058c53-7234-4044-b3c2-ada849938244
Set id: 115e43ea-5b38-495b-b824-80a3abac81a9
Version: 3
Effective Time: 20160927
 
BioActive Nutritional