RXHOMEO HOMEOPATHIC CHILDRENS KIT- rxhomeo homeopathic childrens kit 
Rxhomeo Private Limited d.b.a.

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.

----------

ACTIVE INGREDIENT

ACONITUM NAPELLUS
ALLIUM CEPA
ANTIMONIUM TARTARICUM
APIS MELLIFICA
ARNICA MONTANA
ARSENICUM ALBUM
BELLADONNA
BRYONIA ALBA
CHAMOMILLA
EUPHRASIA OFFICINALIS 
GELSEMIUM SEMPERVIRENS
GLONOINUM
HYPERICUM PERFORATUM 
IPECACUANHA
MERCURIUS SOLUBILIS
NUX VOMICA 
PODOPHYLLUM PELTATUM 
RHUS TOXICODENDRON
FERRUM PHOSPHORICUM
CALENDULA OFFICINALIS

USES

ACONITUM NAPELLUS3X Cold, Flu, Tension
ALLIUM CEPA1XCough & Cold
ANTIMONIUM TARTARICUM3XDry Cough, Congestion
APIS MELLIFICA1XSkin Edema, Insect Bites
ARNICA MONTANA3XBruises, Aches, Pains
ARSENICUM ALBUM6XWeakness, Exhaustion
BELLADONNA3X Fever, Pain, Neuralgia
BRYONIA ALBA3X Flu, Rheumatism
CHAMOMILLA1XBaby Colic, Teething
EUPHRASIA OFFICINALIS1X Conjunctivitis
GELSEMIUM SEMPERVIRENS3X Flu Symptoms
GLONOINUM6X Congestive Headache
HEPAR SULPHURIS CALCAREUM1X Croupy Cough, Boils
HYPERICUM PERFORATUM3X Nerve Trauma & Pain
IPECACUANHA3X Nausea, Vomiting, Cough
MERCURIUS SOLUBILIS6X Sore Throat, Anemia
NUX VOMICA3X Indigestion, Cold, Anxiety
PODOPHYLLUM PELTATUM3XBiliousness
RHUS TOXICODENDRON3XBackache, Urticaria
FERRUM PHOSPHORICUM1XFever, Inflammation
CALENDULA OFF GEL TINC

Minor cuts, scrapes, burns, skin irritation and diaper rash

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE

PELLETS included in the Kit
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.

TABLETS included in the Kit
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.

GEL OINTMENT included in the Kit
Apply a thin layer of Gel to the affected area, repeat 3 times a day or as needed.

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

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 for Pellets.

Aloe Vera Gel for Ointment

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

RXHOMEO HOMEOPATHIC CHILDRENS KIT 
rxhomeo homeopathic childrens kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2452
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-2452-41 in 1 CONTAINER06/01/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 3
Part 4
Part 5
Part 6
Part 7
Part 8
Part 9
Part 10
Part 11
Part 12
Part 13
Part 14
Part 15
Part 16
Part 17
Part 18
Part 19
Part 20
Part 1 of 20
ACONITUM NAPELLUS 
aconitum napellus pellet
Product Information
Item Code (Source)NDC:15631-0005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 2 of 20
ALLIUM CEPA 
allium cepa pellet
Product Information
Item Code (Source)NDC:15631-0015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 3 of 20
ANTIMONIUM TARTARICUM 
antimonium tartaricum pellet
Product Information
Item Code (Source)NDC:15631-0038
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 4 of 20
APIS MELLIFICA 
apis mellifica pellet
Product Information
Item Code (Source)NDC:15631-0039
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 5 of 20
ARSENICUM ALBUM 
arsenicum album pellet
Product Information
Item Code (Source)NDC:15631-0050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 6 of 20
ARNICA MONTANA 
arnica montana pellet
Product Information
Item Code (Source)NDC:15631-0049
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 7 of 20
BELLADONNA 
belladonna pellet
Product Information
Item Code (Source)NDC:15631-0076
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 8 of 20
BRYONIA ALBA 
bryonia alba pellet
Product Information
Item Code (Source)NDC:15631-0087
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 9 of 20
CHAMOMILLA 
chamomilla pellet
Product Information
Item Code (Source)NDC:15631-0123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 10 of 20
EUPHRASIA OFFICINALIS 
euphrasia officinalis pellet
Product Information
Item Code (Source)NDC:15631-0184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 11 of 20
G SEMPERVIRENS 
g sempervirens pellet
Product Information
Item Code (Source)NDC:15631-0589
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 12 of 20
GLONOINUM 
glonoinum pellet
Product Information
Item Code (Source)NDC:15631-0207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 13 of 20
HYPERICUM PERFORATUM 
hypericum perforatum pellet
Product Information
Item Code (Source)NDC:15631-0229
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 14 of 20
IPECACUANHA 
ipecacuanha pellet
Product Information
Item Code (Source)NDC:15631-0237
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 15 of 20
MERCURIUS SOLUBILIS 
mercurius solubilis pellet
Product Information
Item Code (Source)NDC:15631-0295
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 16 of 20
NUX VOMICA 
nux vomica pellet
Product Information
Item Code (Source)NDC:15631-0317
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 17 of 20
PODOPHYLLUM PELTATUM 
podophyllum peltatum pellet
Product Information
Item Code (Source)NDC:15631-0354
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 18 of 20
RHUS TOXICODENDRON 
rhus toxicodendron pellet
Product Information
Item Code (Source)NDC:15631-0374
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 19 of 20
FERRUM PHOSPHORICUM 
ferrum phosphoricum tablet
Product Information
Item Code (Source)NDC:15631-0584
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize3mm
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Part 20 of 20
CALENDULA OFF 
calendula off gel
Product Information
Item Code (Source)NDC:15631-2310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2016
Labeler - Rxhomeo Private Limited d.b.a. (650833994)
Establishment
NameAddressID/FEIBusiness Operations
Rxhomeo Private Limited d.b.a.650833994manufacture(15631-2452)

Revised: 7/2016
Document Id: f1593464-c998-4ef1-8483-5066d497d41a
Set id: adc87f76-9674-4759-a767-a5a1a85cb61b
Version: 1
Effective Time: 20160729
 
Rxhomeo Private Limited d.b.a.