Paeonia Officinalis Pellet [Rxhomeo Private Limited D.b.a. Rxhomeo, Inc] -

PAEONIA OFFICINALIS PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC	15631-0326-0, 15631-0326-1, 15631-0326-2, 15631-0326-3, 15631-0326-4, 15631-0326-5
Set ID	a99d0bed-22ea-4141-ba6c-962a9eafeb45
Category	HUMAN OTC DRUG LABEL
Packager	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

PAEONIA OFFICINALIS HPUS 1X and higher
USES

Anal Fissures
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 preganant, or nursing a baby, seek professional advice before taking this product

Keep this and all medication out of reach of children
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

PAEONIA OFFICINALIS
paeonia officinalis pellet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15631-0326-0	100 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
2	NDC:15631-0326-1	200 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
3	NDC:15631-0326-2	400 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
4	NDC:15631-0326-3	750 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
5	NDC:15631-0326-4	2500 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
6	NDC:15631-0326-5	12500 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/10/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-0326) , label(15631-0326)

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