AZADIRACHTA INDICA- azadirachta indica tablet 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ACTIVE INGREDIENT

AZADIRACHTA INDICA HPUS 1X and Higher

USES

Skin disorders

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

Adults- Take 4 or 6 Tablets 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

Lactose

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

AZADIRACHTA INDICA 
azadirachta indica tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-0531
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI) AZADIRACHTA INDICA BARK1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-0531-01 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:15631-0531-14 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:15631-0531-250 in 1 CONTAINER; Type 0: Not a Combination Product
4NDC:15631-0531-3100 in 1 CONTAINER; Type 0: Not a Combination Product
5NDC:15631-0531-4250 in 1 CONTAINER; Type 0: Not a Combination Product
6NDC:15631-0531-5500 in 1 CONTAINER; Type 0: Not a Combination Product
7NDC:15631-0531-61000 in 1 CONTAINER; Type 0: Not a Combination Product
8NDC:15631-0531-710000 in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/30/2015
Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo, Inc832534981wholesale drug distributor(15631-0531)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-0531) , label(15631-0531)

Revised: 12/2015
Document Id: 9dc18d3f-bfa5-438b-a061-14b43460f463
Set id: d47f6ee5-8609-4992-b54c-66417f37da51
Version: 1
Effective Time: 20151231
 
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc