FDA.reportPublic FDA data

Bronchitis-Asthma

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:59

Label at a glance#

ProductBronchitis-Asthma
Active ingredientInfluenza A Virus, Antimony Potassium Tartrate, Arsenic Trioxide, Bryonia Alba Root, Camphor (natural), Chelidonium Majus, Cinchona Officinalis Bark, Drosera Rotundifolia, Eucalyptus Globulus Leaf, Calcium Sulfide, Histamine Dihydrochloride, Ipecac, Potassium Dichromate, Potassium Carbonate, Potassium Iodide, Lycopodium Clavatum Spore, Myrrh, Sodium Sulfate, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Sanguinaria Canadensis Root, Spongia Officinalis Skeleton, Roasted, Tin, Tussilago Farfara, Verbascum Thapsus, Echinacea, Unspecified, Arctium Lappa Root, Rumex Crispus Root, Influenza B Virus
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Bronchitis-Asthma   Formulated for symptoms associated with bronchitis, pneumonia, asthma, croup and other respiratory system conditions.

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Influenzinum 30x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Camphora 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Lycopodium 15x, Myrrha 15x, Natrum sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sanguinaria 15x, Spongia 15x, Stannum met. 15x, Tussilago farfara 15x, Verbascum 15x, Echinacea 3x, Lappa 3x, Rumex crisp. 3x.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free,non-GMO, organic cane dispensing alcohol 20%

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with bronchitis, pneumonia, asthma, croup and other respiratory system conditions.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256   

WARNINGS SECTION

Warning: Do not use if tamper- evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing of if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4406-12020-01-31C16284748780-19d75b9d0-8803-f424-e053-dadaa90a57ceBronchitis Asthma

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4406-1Bronchitis-Asthma29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4406BRONCHITIS-ASTHMA (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJUS, CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NATRUM SULPHURICUM, NUX VOM., PHOSPHORUS, PULSATILLA, SANGUINARIA, SPONGIA , STANNUM MET., TUSSILAGO FARFARA, VERBASCUM, ECHINACEA, LAPPA, RUMEX CRISP.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20120926_c5e39c9d-6e4f-b4da-c157-a126fb36898e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V31
Arctium Lappa RootACTIVE INGREDIENT597E9BI3Z31
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Camphor (natural)ACTIVE INGREDIENTN20HL7Q9411
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Drosera RotundifoliaACTIVE INGREDIENTQR44N9XPJQ1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Eucalyptus Globulus LeafACTIVE INGREDIENTS546YLW6E61
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U1
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E1
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W1
IpecacACTIVE INGREDIENT62I3C8233L1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
MyrrhACTIVE INGREDIENTJC71GJ1F3L1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Potassium IodideACTIVE INGREDIENT1C4QK22F9J1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Rumex Crispus RootACTIVE INGREDIENT9N1RM2S62C1
Sanguinaria Canadensis RootACTIVE INGREDIENTN9288CD5081
Sodium SulfateACTIVE INGREDIENT0YPR65R21J1
Spongia Officinalis Skeleton, RoastedACTIVE INGREDIENT1PIP394IID1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
TinACTIVE INGREDIENT387GMG9FH51
Tussilago FarfaraACTIVE INGREDIENT0JXZ63016V1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Antimony Cation (3+)ACTIVE MOIETY069647RPT51
Arctium Lappa RootACTIVE MOIETY597E9BI3Z31
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Camphor (natural)ACTIVE MOIETYN20HL7Q9411
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Drosera RotundifoliaACTIVE MOIETYQR44N9XPJQ1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Eucalyptus Globulus LeafACTIVE MOIETYS546YLW6E61
HistamineACTIVE MOIETY820484N8I31
Influenza A VirusACTIVE MOIETYR9HH0NDE2E1
Influenza B VirusACTIVE MOIETY1314JZ2X6W1
Iodide IonACTIVE MOIETY09G4I6V86Q1
IpecacACTIVE MOIETY62I3C8233L1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
MyrrhACTIVE MOIETYJC71GJ1F3L1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Rumex Crispus RootACTIVE MOIETY9N1RM2S62C1
Sanguinaria Canadensis RootACTIVE MOIETYN9288CD5081
Sodium Sulfate AnhydrousACTIVE MOIETY36KCS0R7501
Spongia Officinalis Skeleton, RoastedACTIVE MOIETY1PIP394IID1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
TinACTIVE MOIETY387GMG9FH51
Tussilago FarfaraACTIVE MOIETY0JXZ63016V1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-440655714-4406-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Influenza A VirusR9HH0NDE2EACTIB
Antimony Potassium TartrateDL6OZ476V3ACTIB
Arsenic TrioxideS7V92P67HOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Camphor (natural)N20HL7Q941ACTIB
Chelidonium Majus7E889U5RNNACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Drosera RotundifoliaQR44N9XPJQACTIB
Eucalyptus Globulus LeafS546YLW6E6ACTIB
Calcium Sulfide1MBW07J51QACTIB
Histamine Dihydrochloride3POA0Q644UACTIB
Ipecac62I3C8233LACTIB
Potassium DichromateT4423S18FMACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Potassium Iodide1C4QK22F9JACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
MyrrhJC71GJ1F3LACTIB
Sodium Sulfate0YPR65R21JACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Sanguinaria Canadensis RootN9288CD508ACTIB
Spongia Officinalis Skeleton, Roasted1PIP394IIDACTIB
Tin387GMG9FH5ACTIB
Tussilago Farfara0JXZ63016VACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Arctium Lappa Root597E9BI3Z3ACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Influenza B Virus1314JZ2X6WACTIB
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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 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
dd2e364d-9f27-9e02-970e-1d3986f51593c5e39c9d-6e4f-b4da-c157-a126fb36898e2011-06-01WarningsExact identifier
spl id: dd2e364d-9f27-9e02-970e-1d3986f51593
spl set id: c5e39c9d-6e4f-b4da-c157-a126fb36898e

Reported adverse events (FAERS/openFDA)#

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