FDA.reportPublic FDA data

Bact-In

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-10-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:06:53

Label at a glance#

ProductBact-In
Active ingredientBACILLUS ANTHRACIS IMMUNOSERUM RABBIT, RANCID BEEF, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, GOLDENSEAL, IODINE, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, ECHINACEA, UNSPECIFIED, IRIS VERSICOLOR ROOT, URTICA URENS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Formulated for symptoms such as fever, chills, fatigue, weakness and loss of appetite.

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis 6x, Iris vers. 6x, Urtica ur. 6x, Aconitum nap.15x, Arnica 15x, Arsenicum alb.15x, Baptisia 15x, Bryonia 15x, Hydrastis 15x, Iodium 15x, Lachesis 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Anthracinum 30x, Pyrogenium 30x.

PURPOSE SECTION

INSTRUCTIONS FOR USE SECTION

Formulated for symptoms such as fever, chills, fatigue, weakness and loss of appetite.

INACTIVE INGREDIENT SECTION

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

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 or breast-feeding, ask a doctor before use.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-481855714-4818-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
RANCID BEEF29SUH5R3HUACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
GOLDENSEALZW3Z11D0JVACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
URTICA URENSIHN2NQ5OF9ACTIB
ALCOHOL3K9958V90MIACT

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
b57f515c-27c4-7d26-e053-2995a90abc939532ad07-e75a-10c8-e053-2a95a90a37eb2020-12-02WarningsExact identifier
spl set id: 9532ad07-e75a-10c8-e053-2a95a90a37eb

Reported adverse events (FAERS/openFDA)#

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