HYOSCYAMUS NIGER

Manufacturer: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Effective date: 2021-09-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:14:55

Label at a glance#

ProductHYOSCYAMUS NIGER

Active ingredientHYOSCYAMUS NIGER

Label structure9 sections

Indications and uses

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

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

HYOSCYAMUS NIGER HPUS 3X and higher

USES

OTC - PURPOSE SECTION

USES: Temporary Relief - Headache*

* 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-Label

Label-Pellets

Blister-Pack

Carton-Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15631-0228-0	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-1	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-2	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-3	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-4	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-5	2020-03-20	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-0	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-1	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-2	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-3	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-4	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce
15631-0228-5	2020-01-31	C162847	48780-1	9d75b9d0-21d9-f424-e053-dadaa90a57ce	f7073b53-201d-4831-8784-00bdf95ce3ce

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15631-0228-0	HYOSCYAMUS NIGER	100 in 1 PACKAGE	PELLET	100	3
15631-0228-1	HYOSCYAMUS NIGER	200 in 1 PACKAGE	PELLET	200	3
15631-0228-2	HYOSCYAMUS NIGER	400 in 1 PACKAGE	PELLET	400	3
15631-0228-3	HYOSCYAMUS NIGER	750 in 1 PACKAGE	PELLET	750	3
15631-0228-4	HYOSCYAMUS NIGER	2500 in 1 PACKAGE	PELLET	2500	3
15631-0228-5	HYOSCYAMUS NIGER	12500 in 1 PACKAGE	PELLET	12500	3
15631-0228-6	HYOSCYAMUS NIGER	500 in 1 PACKAGE	PELLET	500	3
15631-0228-7	HYOSCYAMUS NIGER	1000 in 1 PACKAGE	PELLET	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15631-0228	HYOSCYAMUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	3	Current NDC, Legacy NDC, 8 package rows	20210927_f7073b53-201d-4831-8784-00bdf95ce3ce.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	1
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

HYOSCYAMUS NIGER
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15631-0228	15631-0228-0, 15631-0228-1, 15631-0228-2, 15631-0228-3, 15631-0228-4, 15631-0228-5, 15631-0228-6, 15631-0228-7

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
SUCROSE	C151H8M554	IACT
HYOSCYAMUS NIGER	4WRK2153H3	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 279 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii+route 279 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii+route 279 equally ranked IID candidates

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
HYOSCYAMUS NIGER	HYOSCYAMUS NIGER	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	f7073b53-201d-4831-8784-00bdf95ce3ce	2021-09-25	Warnings	Exact identifier ndc (package): 15631-0228-6 ndc (package): 15631-0228-3 ndc (package): 15631-0228-4 ndc (package): 15631-0228-2 ndc (package): 15631-0228-0 ndc (package): 15631-0228-1 ndc (package): 15631-0228-5 ndc (package): 15631-0228-7 ndc (product): 15631-0228 ndc11 (package): 15631022807 ndc11 (package): 15631022806 ndc11 (package): 15631022802 ndc11 (package): 15631022804 ndc11 (package): 15631022803 ndc11 (package): 15631022800 ndc11 (package): 15631022801 ndc11 (package): 15631022805 spl id: ccd270d7-a945-4cf3-e053-2995a90a0f85 spl set id: f7073b53-201d-4831-8784-00bdf95ce3ce

Reported adverse events (FAERS/openFDA)#

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