FDA.reportPublic FDA data

DROSERA ROTUNDIFOLIA

Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
Effective date
2016-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:20

Label at a glance#

ProductDROSERA ROTUNDIFOLIA
Active ingredientDROSERA ROTUNDIFOLIA
Label structure9 sections

Indications and uses

Whooping Cough, Laryngitis

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

DROSERA ROTUNDIFOLIA HPUS 1X and Higher

USES

OTC - PURPOSE SECTION

Whooping Cough, Laryngitis

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Tablets 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

Lactose

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 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0575-02020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-12020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-22020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-32020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-42020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-52020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-62020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4
15631-0575-72020-01-31C16284748780-19d75b9d0-27dc-f424-e053-dadaa90a57ce0af36677-28a7-4e1f-b1c0-a7146cf1b6c4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0575-0DROSERA ROTUNDIFOLIA1 in 1 BLISTER PACKTABLET11
15631-0575-1DROSERA ROTUNDIFOLIA4 in 1 BLISTER PACKTABLET41
15631-0575-2DROSERA ROTUNDIFOLIA50 in 1 CONTAINERTABLET501
15631-0575-3DROSERA ROTUNDIFOLIA100 in 1 CONTAINERTABLET1001
15631-0575-4DROSERA ROTUNDIFOLIA250 in 1 CONTAINERTABLET2501
15631-0575-5DROSERA ROTUNDIFOLIA500 in 1 CONTAINERTABLET5001
15631-0575-6DROSERA ROTUNDIFOLIA1000 in 1 CONTAINERTABLET10001
15631-0575-7DROSERA ROTUNDIFOLIA10000 in 1 CONTAINERTABLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0575DROSERA ROTUNDIFOLIA TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1Legacy NDC, 8 package rows20160107_0af36677-28a7-4e1f-b1c0-a7146cf1b6c4.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
15631-057515631-0575-0, 15631-0575-1, 15631-0575-2, 15631-0575-3, 15631-0575-4, 15631-0575-5, 15631-0575-6, 15631-0575-7

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
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
LACTOSEJ2B2A4N98GIACT

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
070feb38-5117-4d89-b384-8ec811a095620af36677-28a7-4e1f-b1c0-a7146cf1b6c42016-01-06WarningsExact identifier
spl id: 070feb38-5117-4d89-b384-8ec811a09562
spl set id: 0af36677-28a7-4e1f-b1c0-a7146cf1b6c4

Reported adverse events (FAERS/openFDA)#

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