Sabal Serrulata Pellet [Rxhomeo Private Limited D.b.a. Rxhomeo, Inc] -

SABAL SERRULATA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC	15631-0381-0, 15631-0381-1, 15631-0381-2, 15631-0381-3, 15631-0381-4, 15631-0381-5
Set ID	05396d68-f339-4e48-886a-724a3a8ba63e
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

SABAL SERRULATA HPUS 1X and higher
USES

Cystitis, Prostatitis
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

SABAL SERRULATA
sabal serrulata pellet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description
Packaging
1	NDC:15631-0381-0	100 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC:15631-0381-1	200 in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:15631-0381-2	400 in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:15631-0381-3	750 in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:15631-0381-4	2500 in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:15631-0381-5	12500 in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/31/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
Rxhomeo, Inc		832534981	wholesale drug distributor(15631-0381)

Name	Address	ID/FEI	Business Operations
Establishment
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-0381) , label(15631-0381)

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