FDA.reportPublic FDA data

Bryonia

Manufacturer
Newton Laboratories, Inc.
Effective date
2022-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:39

Label at a glance#

ProductBryonia
Active ingredientBRYONIA ALBA ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Aggravation from motion or movement; back pain and stiffness; muscle aches and pain, joint pain and swelling.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth, (ages 0 to 11, give 3 drops) at bedtime or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Bryonia 10x

OTC - PURPOSE SECTION

Aggravation from motion or movement; back pain and stiffness; muscle aches and pain; joint pain and swelling.

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

Warning: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.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-9019-6Bryonia3 L in 1 JUGLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-9019BRYONIA LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20220626_e20b392e-37de-1c83-e053-2995a90a760b.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-901955714-9019-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BRYONIA ALBA ROOTT7J046YI2BACTIB

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
BryoniaBRYONIANewton Laboratories, Inc.e20b392e-37de-1c83-e053-2995a90a760b2022-06-22WarningsExact identifier
ndc (package): 55714-9019-6
ndc (product): 55714-9019
ndc11 (package): 55714901906
spl id: e20b4111-4c6c-18c4-e053-2995a90a5e22
spl set id: e20b392e-37de-1c83-e053-2995a90a760b

Reported adverse events (FAERS/openFDA)#

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