FDA.reportPublic FDA data

Apis Gelsemium Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:29

Label at a glance#

ProductApis Gelsemium Special Order
Active ingredientBERBERIS VULGARIS ROOT BARK, GELSEMIUM SEMPERVIRENS ROOT, APIS MELLIFERA, ARNICA MONTANA ROOT, PSEUDOGNAPHALIUM LUTEOALBUM LEAF, COLCHICUM AUTUMNALE WHOLE, FORMICA RUFA
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Berberis (Barberry) 3X, Gelsemium (Yellow jasmine) 3X, Apis (Honeybee) 4X, Gnaphalium (Edelweiss) 4X, Colchicum (Meadow saffron) 5X, Formica (Red wood ant) 5X, Arnica 10X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ApisGelsemiumSOPelletsApisGelsemiumSOPellets

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-130248951-1302-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
SUCROSEC151H8M554IACT
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANA ROOTMUE8Y11327ACTIB
PSEUDOGNAPHALIUM LUTEOALBUM LEAFBGI20Z6M57ACTIB
COLCHICUM AUTUMNALE WHOLEW79255C628ACTIB
FORMICA RUFA55H0W83JO5ACTIB

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
b467a488-bcfb-6344-e053-2a95a90a05f86d830ddd-8959-1c73-e053-2a91aa0abdb82020-11-18WarningsExact identifier
spl set id: 6d830ddd-8959-1c73-e053-2a91aa0abdb8

Reported adverse events (FAERS/openFDA)#

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