HYOSCYAMUS NIGER by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYOSCYAMUS NIGER pellet

HYOSCYAMUS NIGER by

Drug Labeling and Warnings

HYOSCYAMUS NIGER by is a Homeopathic medication manufactured, distributed, or labeled by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

HYOSCYAMUS NIGER HPUS 3X and higher

USES

Nervous Agitation

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

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

This product is to be used for self-limiting conditions

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

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

Keep this and all medication out of reach of children

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

Sucrose

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

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

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYOSCYAMUS NIGER 
hyoscyamus niger pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15631-0228
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15631-0228-0	100 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 15631-0228-1	200 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 15631-0228-2	400 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
4	NDC: 15631-0228-3	750 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
5	NDC: 15631-0228-4	2500 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
6	NDC: 15631-0228-5	12500 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/02/2015

Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)

Establishment
Name	Address	ID/FEI	Business Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-0228) , label(15631-0228)