Symphytum Officinale Pellet [Rxhomeo Private Limited D.b.a. Rxhomeo, Inc] -

SYMPHYTUM OFFICINALE PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC	15631-0424-0, 15631-0424-1, 15631-0424-2, 15631-0424-3, 15631-0424-4, 15631-0424-5
Set ID	fa22da24-1c23-4040-93a1-612aae89acf4
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

SYMPHYTUM OFFICINALE HPUS 1X and higher
USES

Bone Healing
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

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

SYMPHYTUM OFFICINALE
symphytum officinale pellet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:15631-0424-0	100 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product	01/01/2018
2	NDC:15631-0424-1	200 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
3	NDC:15631-0424-2	400 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
4	NDC:15631-0424-3	750 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
5	NDC:15631-0424-4	2500 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2018
6	NDC:15631-0424-5	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		11/03/2015

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(15631-0424) , label(15631-0424)

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