Cineraria maritima

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:39

Label at a glance#

ProductCineraria maritima
Active ingredientJACOBAEA MARITIMA
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Cineraria maritima 30C HPUS

Less than 10 -12 mg pyrrolizidine alkaloids per pellet

Active ingredient**: See product name on front panel (**contains 0.443 mg of the active ingredient per pellet).

INDICATIONS & USAGE SECTION

Uses: See symptoms on front panel.

Relieves red and irritated eyes *

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

OTC - QUESTIONS SECTION

BoironUSA.com Info@boiron.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1402-412023-11-09C16284748780-1f386c64a-2aa1-0266-e053-dadaa90a7c1aCineraria maritima 30C
0220-1402-412023-01-30C16284748780-1f386c64a-2aa1-0266-e053-dadaa90a7c1aCineraria maritima 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1402-41Cineraria maritima30 [hp_C] in 1 TUBEPELLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1402CINERARIA MARITIMA (JACOBAEA MARITIMA ) PELLET [BOIRON]3Current NDC, Legacy NDC, 1 package rows20240418_87353a5e-e86a-d35e-e053-2991aa0ae0b0.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
0220-14020220-1402-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
Cineraria maritimaJACOBAEA MARITIMABoiron87353a5e-e86a-d35e-e053-2991aa0ae0b02024-04-17Exact identifier
ndc (package): 0220-1402-41
ndc (product): 0220-1402
ndc11 (package): 00220140241
spl id: 164b92ef-5544-aca4-e063-6294a90a93c4
spl set id: 87353a5e-e86a-d35e-e053-2991aa0ae0b0

Reported adverse events (FAERS/openFDA)#

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