FDA.reportPublic FDA data

Homeopathic Sinus Relief

Manufacturer
Indiana Botanic Gardens | ASI Marketing Group
Effective date
2016-08-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:24:27

Label at a glance#

ProductHomeopathic Sinus Relief
Active ingredientONION, ATROPA BELLADONNA, EUPHRASIA STRICTA, POTASSIUM DICHROMATE, CALOMEL, SAMBUCUS NIGRA FLOWERING TOP, THUJA OCCIDENTALIS LEAFY TWIG
Label structure13 sections

Label contents#

Full prescribing information#

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Red Onion ......................... 3C HPUS

Deadly Nightshade .............3C HPUS

Eyebright ............................3C HPUS

Potassium bichromate ...........3C HPUS

Calomel ..............................6C HPUS

European elder ...................3C HPUS

Arbor vitae ..........................3C HPUS

SPL UNCLASSIFIED SECTION

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Dextrose, Magnesium Stearate, Silica.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE. HOBART, IN 46342

Suggested Use:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years, take 1-2 tablets, dissolve under tongue or chew 3 times a day or as directed by a health professional. Take 15 minutes before or after meals.

OTC - STOP USE SECTION

If symptoms persist for more than 7 days consult a health professional.

Warning:

WARNINGS SECTION

If you are taking any medications or are pregnant or breast feeding do not use prior to consulting a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

For your protection, this container has an outer safety seal. (Do not accept if missing or broken.)

Best if used by date on bottle. Store in a dry cool place.

OTC - PURPOSE SECTION

For temporary relief of sinus pain and nasal discharge.

INDICATIONS & USAGE SECTION

For temporary relief of sinus pain and nasal discharge.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Homeopathic Sinus Relief

For temporary relief of sinus pain and nasal discharge.

90 TABLETS

image of label
image of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10578-127-902021-01-15C16284748780-19d75b9d0-cf79-f424-e053-dadaa90a57ceHomeopathic Sinus Relief
10578-127-902020-01-31C16284748780-19d75b9d0-cf79-f424-e053-dadaa90a57ceHomeopathic Sinus Relief

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10578-12710578-127-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
CALOMELJ2D46N657DACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
DEXTROSEIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
704dee5e-52f8-465f-b753-a439e92c9a2984c9d497-b2ef-4120-95c5-da4d9e3ebe982021-01-15WarningsExact identifier
spl set id: 84c9d497-b2ef-4120-95c5-da4d9e3ebe98

Reported adverse events (FAERS/openFDA)#

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