FDA.reportPublic FDA data

Gentian Ginger Bitters

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2022-05-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:00:57

Label at a glance#

ProductGentian Ginger Bitters
Active ingredientACORUS CALAMUS ROOT, WHITE PEPPER, WORMWOOD, GINGER, GENTIANA LUTEA ROOT
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily before or after meals and/or snacks. Ages 12 and older: 1/4 teaspoon. Ages 2-11: 1/8 teaspoon. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 1gm contains: 350mg Gentiana (Yellow gentian) 1X, 277mg Absinthium (Wormwood) 1X, 223mg Zingiberis (Ginger root) 1X, 36.7mg Calamus (Sweet flag) 1X, 6.7mg Piper nigrum (Black peppercorns) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Distilled water

OTC - PURPOSE SECTION

Uses: Improves digestion; eases gas and indigestion.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentian Ginger BittersGentian Ginger Bitters

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-500648951-5006-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACORUS CALAMUS ROOTXY1K7KIQ0FACTIB
WHITE PEPPERM29DW54Q9EACTIB
WORMWOODF84709P2XVACTIB
GINGERC5529G5JPQACTIB
WATER059QF0KO0RIACT
GENTIANA LUTEA ROOTS72O3284MSACTIB

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
26cde32b-3395-284b-e063-6394a90a8cd0df5e8e31-148e-8e81-e053-2a95a90a733a2024-11-13WarningsExact identifier
spl set id: df5e8e31-148e-8e81-e053-2a95a90a733a

Reported adverse events (FAERS/openFDA)#

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