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

QUEBRACHO PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC	15631-0360-0, 15631-0360-1, 15631-0360-2, 15631-0360-3, 15631-0360-4, 15631-0360-5
Set ID	5964a349-19a5-40d7-a8a9-4c6d82867f15
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

QUEBRACHO HPUS 1X and higher
USES

Fever & Cough
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
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

QUEBRACHO
quebracho pellet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190)	ASPIDOSPERMA QUEBRACHO-BLANCO BARK	1 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description
Packaging
1	NDC:15631-0360-0	100 in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:15631-0360-1	200 in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:15631-0360-2	400 in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:15631-0360-3	750 in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:15631-0360-4	2500 in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:15631-0360-5	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		10/05/2015

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

Name	Address	ID/FEI	Business Operations
Establishment
Rxhomeo, Inc		832534981	wholesale drug distributor(15631-0360)

Name	Address	ID/FEI	Business Operations
Establishment
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-0360) , label(15631-0360)

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