Rxhomeo Homeopathic Family Kit: Homeopathic Product Information

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.

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	3X	Backache, 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.comRxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RXHOMEO HOMEOPATHIC FAMILY KIT rxhomeo homeopathic family kit kit

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15631-2451

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:15631-2451-1 1 KIT in 1 CONTAINER None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 3 1 Part 4 1 Part 5 1 Part 6 1 Part 7 1 Part 8 1 Part 9 1 Part 10 1 Part 11 1 Part 12 1 Part 13 1 Part 14 1 Part 15 1 Part 16 1 Part 17 1 Part 18 1 Part 19 1 Part 20 1

Part 1 of 20 ACONITUM NAPELLUS aconitum napellus pellet

Product Information Item Code (Source) NDC:15631-0005 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 2 of 20 ALLIUM CEPA allium cepa pellet

Product Information Item Code (Source) NDC:15631-0015 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (ONION) ONION 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 3 of 20 ALOE SOCOTRINA aloe socotrina pellet

Product Information Item Code (Source) NDC:15631-0018 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALOE (ALOE) ALOE 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 4 of 20 ARNICA MONTANA arnica montana pellet

Product Information Item Code (Source) NDC:15631-0049 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 5 of 20 BELLADONNA belladonna pellet

Product Information Item Code (Source) NDC:15631-0076 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 6 of 20 BRYONIA ALBA bryonia alba pellet

Product Information Item Code (Source) NDC:15631-0087 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 7 of 20 CARBO VEGETABILIS carbo vegetabilis pellet

Product Information Item Code (Source) NDC:15631-0108 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 8 of 20 COLOCYNTHIS colocynthis pellet

Product Information Item Code (Source) NDC:15631-0152 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 9 of 20 EUPHRASIA OFFICINALIS euphrasia officinalis pellet

Product Information Item Code (Source) NDC:15631-0184 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 10 of 20 G SEMPERVIRENS g sempervirens pellet

Product Information Item Code (Source) NDC:15631-0589 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 11 of 20 GLONOINUM glonoinum pellet

Product Information Item Code (Source) NDC:15631-0207 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 6 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing 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 Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 13 of 20 HYPERICUM PERFORATUM hypericum perforatum pellet

Product Information Item Code (Source) NDC:15631-0229 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 14 of 20 IPECACUANHA ipecacuanha pellet

Product Information Item Code (Source) NDC:15631-0237 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IPECAC (IPECAC) IPECAC 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 15 of 20 MERCURIUS SOLUBILIS mercurius solubilis pellet

Product Information Item Code (Source) NDC:15631-0295 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 6 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 16 of 20 NUX VOMICA nux vomica pellet

Product Information Item Code (Source) NDC:15631-0317 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 17 of 20 PLANTAGO MAJOR plantago major pellet

Product Information Item Code (Source) NDC:15631-0347 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 18 of 20 PULSATILLA pulsatilla pellet

Product Information Item Code (Source) NDC:15631-0357 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PULSATILLA VULGARIS (ANEMONE PULSATILLA) PULSATILLA VULGARIS 1 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 19 of 20 RHUS TOXICODENDRON rhus toxicodendron pellet

Product Information Item Code (Source) NDC:15631-0374 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 3 [hp_X]

Inactive Ingredients Ingredient Name Strength SUCROSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Part 20 of 20 CALENDULA OFF calendula off gel

Product Information Item Code (Source) NDC:15631-2310 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 g

Inactive Ingredients Ingredient Name Strength ALOE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2016

Labeler — Rxhomeo Private Limited d.b.a. (650833994)

Establishment
Name	Address	ID/FEI	Operations
Rxhomeo Private Limited d.b.a.		650833994	manufacture (15631-2451)

Revised: 06/2016 Rxhomeo Private Limited d.b.a.