RXHOMEO HOMEOPATHIC FAMILY KIT- rxhomeo homeopathic family 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.

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ACTIVE INGREDIENT

ACONITUM NAPELLUS
ALLIUM CEPA
ALOE SOCOTRINA
ARNICA MONTANA
BELLADONNA
BRYONIA ALBA
CALENDULA OFFICINALIS
CARBO VEGETABILIS
COLOCYNTHIS
EUPHRASIA OFFICINALIS
GELSEMIUM SEMPERVIRENS
GLONOINUM
HEPAR SULPHURIS CALCAREUM
HYPERICUM PERFORATUM
IPECACUANHA
MERCURIUS SOLUBILIS
NUX VOMICA
PLANTAGO MAJOR
PULSATILLA
RHUS TOXICODENDRON
CALENDULA OFF GEL

USES

ACONITUM NAPELLUS 3X Cold, Flu, Tension
ALLIUM CEPA 1X Cough & Cold
ALOE SOCOTRINA 1X Hemorrhoids, Diarrhea                  
ARNICA MONTANA 3X Bruises, Aches, Pains
BELLADONNA 3X Fever, Pain, Neuralgia
BRYONIA ALBA 3X Flu, Rheumatism
CARBO VEGETABILIS 1X Dyspepsia, Flatulence
COLOCYNTHIS 3X Abdominal Cramps
EUPHRASIA OFFICINALIS 1X Conjunctivitis
GELSEMIUM SEMPERVIRENS 3X Flu Symptoms
GLONOINUM 6X Congestive Headache
HEPAR SULPHURIS CALCAREUM 1X Croupy Cough, Boils
HYPERICUM PERFORATUM 3X Nerve Trauma & Pain
IPECACUANHA 3X Nausea, Vomiting, Cough
MERCURIUS SOLUBILIS 6X Sore Throat, Anemia
NUX VOMICA 3X Indigestion, Cold, Anxiety
PLANTAGO MAJOR 1X Ear & Toothache
PULSATILLA 1X Nasal Catarrh, Pms
RHUS TOXICODENDRON 3XBackache, Urticaria
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.

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 FAMILY KIT 
rxhomeo homeopathic family kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2451
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15631-2451-11 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
ALOE SOCOTRINA 
aloe socotrina pellet
Product Information
Item Code (Source)NDC:15631-0018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE1 [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
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 5 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 6 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 7 of 20
CARBO VEGETABILIS 
carbo vegetabilis pellet
Product Information
Item Code (Source)NDC:15631-0108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 [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
COLOCYNTHIS 
colocynthis pellet
Product Information
Item Code (Source)NDC:15631-0152
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [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
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 10 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 11 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 12 of 20
HEPAR SULPHURIS CALCAREUM 
hepar sulphuris calcareum pellet
Product Information
Item Code (Source)NDC:15631-0224
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE1 [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
PLANTAGO MAJOR 
plantago major pellet
Product Information
Item Code (Source)NDC:15631-0347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [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
PULSATILLA 
pulsatilla pellet
Product Information
Item Code (Source)NDC:15631-0357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS1 [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
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 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(15631-2451)

Revised: 6/2016
Document Id: 0be51b2a-0116-418a-a529-8966aacfca71
Set id: 9c5fa215-5ed9-4fd1-9858-4c75d7e04a8c
Version: 1
Effective Time: 20160607
 
Rxhomeo Private Limited d.b.a.