Syzygium jambolanum

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-11-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:49

Label at a glance#

ProductSyzygium jambolanum
Active ingredientSYZYGIUM CUMINI SEED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Syzygium jambolanum 30C

(**contains 0.443 mg of the active ingredient per pellet)

INDICATIONS & USAGE SECTION

Rx Only*

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

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.

INACTIVE INGREDIENT SECTION

lactose, sucrose

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-7842-412023-11-15C16284748780-1f386c64a-3199-0266-e053-dadaa90a7c1aSyzygium jambolanum 30C
0220-7842-412023-01-30C16284748780-1f386c64a-3199-0266-e053-dadaa90a7c1aSyzygium jambolanum 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-7842-41Syzygium jambolanum30 [hp_C] in 1 TUBEPELLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-7842SYZYGIUM JAMBOLANUM (SYZYGIUM CUMINI SEED ) PELLET [BOIRON]2Current NDC, Legacy NDC, 1 package rows20231116_8771ba77-5c98-5c94-e053-2a95a90ac57d.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
0220-78420220-7842-41

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
Syzygium jambolanumSYZYGIUM CUMINI SEEDBoiron8771ba77-5c98-5c94-e053-2a95a90ac57d2023-11-15Exact identifier
ndc (package): 0220-7842-41
ndc (product): 0220-7842
ndc11 (package): 00220784241
spl id: 0a364a68-011b-5f71-e063-6394a90afc82
spl set id: 8771ba77-5c98-5c94-e053-2a95a90ac57d

Reported adverse events (FAERS/openFDA)#

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