FDA.reportPublic FDA data

SPIGELIA ANTHELMIA

Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Effective date
2021-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:06

Label at a glance#

ProductSPIGELIA ANTHELMIA
Active ingredientSPIGELIA ANTHELMIA
Label structure9 sections

Indications and uses

USES: Temporary Relief - Nasal Congestion* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

SPIGELIA ANTHELMIA HPUS 2X and higher

USES

OTC - PURPOSE SECTION

USES: Temporary Relief - Nasal Congestion*

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional.

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

www.rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mini-LabelMini-Label

Label-PelletsLabel-Pellets

Blister-labelBlister-label

carton-labelcarton-label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0409-02023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-12023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-22023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-32023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-42023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-52023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-62023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0
15631-0409-72023-01-30C16284748780-1f386c64a-3a5b-0266-e053-dadaa90a7c1ace144468-65d7-e5ec-e053-2995a90a42f0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0409-0SPIGELIA ANTHELMIA100 in 1 PACKAGEPELLET1001
15631-0409-1SPIGELIA ANTHELMIA200 in 1 PACKAGEPELLET2001
15631-0409-2SPIGELIA ANTHELMIA400 in 1 PACKAGEPELLET4001
15631-0409-3SPIGELIA ANTHELMIA750 in 1 PACKAGEPELLET7501
15631-0409-4SPIGELIA ANTHELMIA2500 in 1 PACKAGEPELLET25001
15631-0409-5SPIGELIA ANTHELMIA12500 in 1 PACKAGEPELLET125001
15631-0409-6SPIGELIA ANTHELMIA500 in 1 PACKAGEPELLET5001
15631-0409-7SPIGELIA ANTHELMIA1000 in 1 PACKAGEPELLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0409SPIGELIA ANTHELMIA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1Legacy NDC, 8 package rows20211014_ce144468-65d7-e5ec-e053-2995a90a42f0.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15631-040915631-0409-0, 15631-0409-1, 15631-0409-2, 15631-0409-3, 15631-0409-4, 15631-0409-5, 15631-0409-6, 15631-0409-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
SPIGELIA ANTHELMIAWYT05213GEACTIB

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
ce144468-65d8-e5ec-e053-2995a90a42f0ce144468-65d7-e5ec-e053-2995a90a42f02021-10-11WarningsExact identifier
spl id: ce144468-65d8-e5ec-e053-2995a90a42f0
spl set id: ce144468-65d7-e5ec-e053-2995a90a42f0

Reported adverse events (FAERS/openFDA)#

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