FDA.reportPublic FDA data

Coumarin

Manufacturer
Apotheca Company
Effective date
2022-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:48:03

Label at a glance#

ProductCoumarin
Active ingredientCOUMARIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:  Coumarin 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C.

OTC - PURPOSE SECTION

INDICATIONS:  For temporary relief of allergies caused by dairy products, foods, tobacco, wheat, bowel disorders including celiac disease, colitis, poor digestion, back and neck pain and asthma.

WARNINGS SECTION

WARNINGS:  Keep out of reach of children.  In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal:  "Sealed for Your Protection."  Do not use if seal is broken or missing.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  1-10 drops under the tongue, 3 times a day or as directed by a health professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, contact physician or Poison Control Center right away.

INDICATIONS & USAGE SECTION

INDICATIONS:  For temporary relief of allergies caused by dairy products, foods, tobacco, wheat, bowel disorders including celiac disease, colitis, poor digestion, back and neck pain and asthma.

OTC - QUESTIONS SECTION

Dist. By:

Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070

www.desbio.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO

NED 57520-1001-1

HOMEOPATHIC

COUMARIN

1 FL OZ (30 ml)

CoumarinCoumarin

CoumarinCoumarin

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-1001-12022-11-14C16284748780-19d75b9d0-dc27-f424-e053-dadaa90a57ceCoumarin
57520-1001-12020-01-31C16284748780-19d75b9d0-dc27-f424-e053-dadaa90a57ceCoumarin

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
COUMARINACTIVE INGREDIENTA4VZ22K1WT1
COUMARINACTIVE MOIETYA4VZ22K1WT1

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
57520-100157520-1001-1

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
COUMARINA4VZ22K1WTACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
62eb7062-f7de-4da2-858b-1fb3408709b6638f5a02-0f10-4cbc-87f8-5b5d4fef209b2022-11-14WarningsExact identifier
spl id: 62eb7062-f7de-4da2-858b-1fb3408709b6
spl set id: 638f5a02-0f10-4cbc-87f8-5b5d4fef209b

Reported adverse events (FAERS/openFDA)#

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