Label: RXHOMEO HOMEOPATHIC CHILDRENS KIT- rxhomeo homeopathic childrens kit

  • NDC Code(s): 15631-2452-4
  • Packager: Rxhomeo Private Limited d.b.a.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated July 29, 2016

If you are a consumer or patient please visit this version.

  • 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

    Close
  • USES

    ACONITUM NAPELLUS 3X  Cold, Flu, Tension
    ALLIUM CEPA 1X Cough & Cold
    ANTIMONIUM TARTARICUM 3X Dry Cough, Congestion
    APIS MELLIFICA 1X Skin Edema, Insect Bites
    ARNICA MONTANA 3X Bruises, Aches, Pains
    ARSENICUM ALBUM 6X Weakness, Exhaustion
    BELLADONNA 3X  Fever, Pain, Neuralgia
    BRYONIA ALBA 3X  Flu, Rheumatism
    CHAMOMILLA 1X Baby Colic, Teething
    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
    PODOPHYLLUM PELTATUM 3X Biliousness
    RHUS TOXICODENDRON 3X Backache, Urticaria
    FERRUM PHOSPHORICUM 1X Fever, Inflammation
    CALENDULA OFF GEL  TINC

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

    Close
  • INDICATIONS

    Condition listed above or as directed by the physician

    Close
  • 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.

    Close
  • 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.

    Close
  • INACTIVE INGREDIENTS

    Sucrose for Pellets.

    Aloe Vera Gel for Ointment

    Close
  • STORAGE

    Store in a cool dark place

    Close
  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com
    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    RXHOMEO HOMEOPATHIC CHILDRENS KIT 
    rxhomeo homeopathic childrens kit kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:15631-2452
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15631-2452-4 1 in 1 CONTAINER 06/01/2016
    Quantity of Parts
    Part # Package Quantity Total 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 Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 3 of 20
    ANTIMONIUM TARTARICUM 
    antimonium tartaricum pellet
    Product Information
    Item Code (Source) NDC:15631-0038
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 4 of 20
    APIS MELLIFICA 
    apis mellifica pellet
    Product Information
    Item Code (Source) NDC:15631-0039
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 5 of 20
    ARSENICUM ALBUM 
    arsenicum album pellet
    Product Information
    Item Code (Source) NDC:15631-0050
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 6 of 20
    ARNICA MONTANA 
    arnica montana pellet
    Product Information
    Item Code (Source) NDC:15631-0049
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 7 of 20
    BELLADONNA 
    belladonna pellet
    Product Information
    Item Code (Source) NDC:15631-0076
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 8 of 20
    BRYONIA ALBA 
    bryonia alba pellet
    Product Information
    Item Code (Source) NDC:15631-0087
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 9 of 20
    CHAMOMILLA 
    chamomilla pellet
    Product Information
    Item Code (Source) NDC:15631-0123
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 10 of 20
    EUPHRASIA OFFICINALIS 
    euphrasia officinalis pellet
    Product Information
    Item Code (Source) NDC:15631-0184
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 11 of 20
    G SEMPERVIRENS 
    g sempervirens pellet
    Product Information
    Item Code (Source) NDC:15631-0589
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 12 of 20
    GLONOINUM 
    glonoinum pellet
    Product Information
    Item Code (Source) NDC:15631-0207
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 17 of 20
    PODOPHYLLUM PELTATUM 
    podophyllum peltatum pellet
    Product Information
    Item Code (Source) NDC:15631-0354
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 18 of 20
    RHUS TOXICODENDRON 
    rhus toxicodendron pellet
    Product Information
    Item Code (Source) NDC:15631-0374
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic
    Part 19 of 20
    FERRUM PHOSPHORICUM 
    ferrum phosphoricum tablet
    Product Information
    Item Code (Source) NDC:15631-0584
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 1 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 3mm
    Flavor Imprint Code
    Contains     
    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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE (UNII: V5VD430YW9)  
    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 Business Operations
    Rxhomeo Private Limited d.b.a. 650833994 manufacture(15631-2452)
    Close