FDA.reportPublic FDA data

BronCare

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:13:44

Label at a glance#

ProductBronCare
Active ingredientCINCHONA OFFICINALIS BARK, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, IPECAC, ARCTIUM LAPPA ROOT, ANEMONE PULSATILLA, DROSERA ANGLICA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, VERBASCUM THAPSUS, POTASSIUM DICHROMATE, SODIUM SULFATE, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, TUSSILAGO FARFARA, CHELIDONIUM MAJUS, TIN, INFLUENZA B VIRUS, STRYCHNOS NUX-VOMICA SEED, SANGUINARIA CANADENSIS ROOT, INFLUENZA A VIRUS, RUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, POTASSIUM IODIDE, ARSENIC TRIOXIDE, CAMPHOR (NATURAL), ECHINACEA, UNSPECIFIED, POTASSIUM CARBONATE, MYRRH
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as excess mucus, cough, congestion and shortness of breath.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Lappa 6x, Rumex crisp. 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Camphora 15x, Chelidonium maj. 13x, Cinchona 13x, Drosera 13x, Eucalyptus 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Lycopodium 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Sanguinaria 15x, Spongia 15x, Stannum met. 15x, Tussilago far. 15x, Verbascum 15x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such as excess mucus, cough, congestion and shortness of breath.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4840-1BronCare28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4840BRONCARE (ECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUM) PELLET [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20200520_a5281807-675f-07f7-e053-2995a90a3a8a.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-484055714-4840-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
IPECAC62I3C8233LACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
DROSERA ANGLICAJ61BY05EGYACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
SODIUM SULFATE0YPR65R21JACTIB
SUCROSEC151H8M554IACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
TUSSILAGO FARFARA0JXZ63016VACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
TIN387GMG9FH5ACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MYRRHJC71GJ1F3LACTIB

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
BronCareECHINACEA, LAPPA, RUMEX CRISP., ANTIMON. TART., ARSENICUM ALB., BRYONIA, CAMPHORA, CHELIDONIUM MAJ., CINCHONA, DROSERA, EUCALYPTUS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, IPECAC., KALI BIC., KALI CARB., KALI IOD., LYCOPODIUM, MYRRHA, NAT. SULPHURICUM, NUX VOM., PHOS., PULSATILLA, SAINGUINARIA, SPONGIA, STANNUM MET., TUSSILAGO FAR., VERBASCUM, INFLUENZINUMNewton Laboratories, Inc.a5281807-675f-07f7-e053-2995a90a3a8a2020-05-18WarningsExact identifier
ndc (package): 55714-4840-1
ndc (product): 55714-4840
ndc11 (package): 55714484001
spl id: a5281830-e6f3-0ae7-e053-2995a90a8ed6
spl set id: a5281807-675f-07f7-e053-2995a90a3a8a

Reported adverse events (FAERS/openFDA)#

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