PASSIFLORA INCARNATA

Manufacturer: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
Effective date: 2015-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:07:02

Label at a glance#

ProductPASSIFLORA INCARNATA

Active ingredientPASSIFLORA INCARNATA FLOWERING TOP

Label structure9 sections

Indications and uses

Insomnia

Storage and handling

Store in a cool dark place

Contacts and useful links#

Websitewww.rxhomeo.com

www.Rxhomeo.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

PASSIFLORA INCARNATA HPUS 1X and Higher

USES

OTC - PURPOSE SECTION

Insomnia

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

SPL UNCLASSIFIED SECTION

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15631-0648-0	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-1	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-2	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-3	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-4	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-5	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-6	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d
15631-0648-7	2020-01-31	C162847	48780-1	9d75b9d0-27b8-f424-e053-dadaa90a57ce	0ddf37ea-189f-4a6c-8116-64ce8645769d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15631-0648-0	PASSIFLORA INCARNATA	1 in 1 BLISTER PACK	TABLET	1	1
15631-0648-1	PASSIFLORA INCARNATA	4 in 1 BLISTER PACK	TABLET	4	1
15631-0648-2	PASSIFLORA INCARNATA	50 in 1 CONTAINER	TABLET	50	1
15631-0648-3	PASSIFLORA INCARNATA	100 in 1 CONTAINER	TABLET	100	1
15631-0648-4	PASSIFLORA INCARNATA	250 in 1 CONTAINER	TABLET	250	1
15631-0648-5	PASSIFLORA INCARNATA	500 in 1 CONTAINER	TABLET	500	1
15631-0648-6	PASSIFLORA INCARNATA	1000 in 1 CONTAINER	TABLET	1000	1
15631-0648-7	PASSIFLORA INCARNATA	10000 in 1 CONTAINER	TABLET	10000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15631-0648	PASSIFLORA INCARNATA TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	1	Legacy NDC, 8 package rows	20151229_0ddf37ea-189f-4a6c-8116-64ce8645769d.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

PASSIFLORA INCARNATA
PASSIFLORA INCARNATA FLOWERING TOP
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15631-0648	15631-0648-0, 15631-0648-1, 15631-0648-2, 15631-0648-3, 15631-0648-4, 15631-0648-5, 15631-0648-6, 15631-0648-7

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
Name	UNII	Kind
PASSIFLORA INCARNATA FLOWERING TOP	CLF5YFS11O	ACTIB
LACTOSE	J2B2A4N98G	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
88b616de-61a9-46d3-9e5e-833d29398562			0ddf37ea-189f-4a6c-8116-64ce8645769d	2015-12-26	Warnings	Exact identifier spl id: 88b616de-61a9-46d3-9e5e-833d29398562 spl set id: 0ddf37ea-189f-4a6c-8116-64ce8645769d

Reported adverse events (FAERS/openFDA)#

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