FDA.reportPublic FDA data

Ferrum Acidum cholalicum 4 Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:17

Label at a glance#

ProductFerrum Acidum cholalicum 4 Special Order
Active ingredientCHOLIC ACID, HONEY, FERROUS GLUCONATE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon.
Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Acidicum cholalicum 4X, Ferrum gluconicum 4X, Mel 4X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Lactose

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warning: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains lactose. 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

FerrumAcidumCholalicum4SpecialOrderPowderFerrumAcidumCholalicum4SpecialOrderPowder

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f99d8137-bd66-44a7-97c0-687c5d02cfc7Product name120150417

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4139-4Ferrum Acidum cholalicum 4 Special Order50 g in 1 BOTTLE, GLASSPOWDER501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4139FERRUM ACIDUM CHOLALICUM 4 SPECIAL ORDER POWDER [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20180607_6b6741df-9dd7-2fe9-e053-2a91aa0ae398.zip

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
48951-413948951-4139-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLIC ACIDG1JO7801AEACTIB
HONEYY9H1V576FHACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
FERROUS GLUCONATEU1B11I423ZACTIM

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
6b6741df-9dd8-2fe9-e053-2a91aa0ae3986b6741df-9dd7-2fe9-e053-2a91aa0ae3982018-05-04WarningsExact identifier
spl id: 6b6741df-9dd8-2fe9-e053-2a91aa0ae398
spl set id: 6b6741df-9dd7-2fe9-e053-2a91aa0ae398

Reported adverse events (FAERS/openFDA)#

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