Syzygium jambolanum

SYZYGIUM CUMINI SEED ORAL HUMAN PRESCRIPTION DRUG

Syzygium jambolanum is an FDA drug label for the active ingredient SYZYGIUM CUMINI SEED manufactured by Boiron administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231115.

Generic name
SYZYGIUM CUMINI SEED
Manufacturer
Boiron
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Dosage form
N/A
NDC
0220-7842
Application
N/A
Label effective
20231115

About this product

Syzygium jambolanum is an FDA-registered drug product whose active ingredient is SYZYGIUM CUMINI SEED. It is labelled by Boiron taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0220-7842, label effective 20231115. It is one of 2 FDA drug label records sharing the active ingredient SYZYGIUM CUMINI SEED. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Active ingredients

Syzygium jambolanum 30C (**contains 0.443 mg of the active ingredient per pellet)

Indications & Usage

Rx Only*

Dosage & Administration

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.

How products containing SYZYGIUM CUMINI SEED compare

FDA lists 2 drug label records with SYZYGIUM CUMINI SEED as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Boiron 2
— — — —
— — — —
— — — —
— — — —

Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0803-2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA Boiron Inc. Class III Terminated 20180523

Frequently asked questions

What is Syzygium jambolanum used for?
Rx Only*

Who makes Syzygium jambolanum?
Boiron is the labeler of record for Syzygium jambolanum. 2 FDA label records share the active ingredient SYZYGIUM CUMINI SEED, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Syzygium jambolanum come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Syzygium jambolanum prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SYZYGIUM CUMINI SEED?
Yes. 2 FDA drug label records list SYZYGIUM CUMINI SEED as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Syzygium jambolanum been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.