Bromium

Manufacturer
Boiron | Boiron Inc.
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:23:10

Label at a glance#

ProductBromium
Active ingredientBROMINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BROMIUM HPUS

6X 6C 30C

INDICATIONS & USAGE SECTION

Sore throat pain worsened by heat*

OTC - STOP USE SECTION

STOP USE AND SEE 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

5 PELLETS 3 TIMES A DAY UNTIL SYMPTOMS ARE RELIEVED

SPL UNCLASSIFIED SECTION

DO NOT USE IF PELLET DISPENSER SEAL IS BROKEN

CONTAINS APPROX 80 PELLETS

INACTIVE INGREDIENT SECTION

LACTOSE, SUCROSE

OTC - QUESTIONS SECTION

1-800-BOIRON-1

Newtown Square, PA 19073-3267

info@boironusa.com

SPL UNCLASSIFIED SECTION

These "uses" have not been evaluated by the FDA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-0907-412023-11-09C16284748780-1f386c649-aef9-0266-e053-dadaa90a7c1aBromium
0220-0907-412023-01-30C16284748780-1f386c649-aef9-0266-e053-dadaa90a7c1aBromium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0907-41Bromium6 [hp_X] in 1 TUBEPELLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-0907BROMIUM (BROMINE) PELLET [BOIRON]3Current NDC, Legacy NDC, 1 package rows20231110_6853c1e8-8a6a-26ac-e053-2991aa0ad85b.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
0220-09070220-0907-41

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
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
BROMINESBV4XY874GACTIB
SUCROSEC151H8M554IACT

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
BromiumBROMINEBoiron6853c1e8-8a6a-26ac-e053-2991aa0ad85b2023-11-09Exact identifier
ndc (package): 0220-0907-41
ndc (product): 0220-0907
ndc11 (package): 00220090741
spl id: 09bac992-8029-5dee-e063-6394a90a7e0d
spl set id: 6853c1e8-8a6a-26ac-e053-2991aa0ad85b

Reported adverse events (FAERS/openFDA)#

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