FDA.reportPublic FDA data

Bach Original Flower Remedies Gentian

Manufacturer
Nelson Bach USA Limited | A. Nelson & Co. Limited
Effective date
2022-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:11

Label at a glance#

ProductBach Original Flower Remedies Gentian
Active ingredientGENTIANELLA AMARELLA FLOWER
Label structure9 sections

Dosage and administration

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day. Children under 2: ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Gentian (Gentiana amarella) 5X HPUS

‘HPUS’ indicates the ingredient is in the official Homeopathic Pharmacopoeia of the United States

Purpose

OTC - PURPOSE SECTION

Accept setbacks

Use

INDICATIONS & USAGE SECTION

For relief of naturally occurring simple nervous tension

Warnings

WARNINGS SECTION

Consult a doctor if symptoms last for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.

Children under 2: ask a doctor before use.

Other information

OTHER SAFETY INFORMATION

Store below 77 ºF (25 ºC)

Do not use if tamper evident seal around bottle neck is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin [vegetable], purified water

Questions

OTC - QUESTIONS SECTION

800-319-9151 8am-5pm (EST) Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bach Original Flower Remedies GentianBach Original Flower Remedies Gentian

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-211-10Bach Original Flower Remedies Gentian1 in 1 CARTONSOLUTION11
57687-211-10Bach Original Flower Remedies Gentian10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-211BACH ORIGINAL FLOWER REMEDIES GENTIAN (GENTIANA AMARELLA) SOLUTION [NELSON BACH USA LIMITED]1Current NDC, Legacy NDC, 2 package rows20221001_e9d4bacf-5bc8-b7df-e053-2995a90ab28e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57687-21157687-211-10

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
GENTIANELLA AMARELLA FLOWERZKH2SOY1ARACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
Bach Original Flower Remedies GentianGENTIANA AMARELLANelson Bach USA Limitede9d4bacf-5bc8-b7df-e053-2995a90ab28e2022-09-29WarningsExact identifier
ndc (package): 57687-211-10
ndc (product): 57687-211
ndc11 (package): 57687021110
spl id: e9d4bacf-5bc9-b7df-e053-2995a90ab28e
spl set id: e9d4bacf-5bc8-b7df-e053-2995a90ab28e

Reported adverse events (FAERS/openFDA)#

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