Label: RXHOMEO HOMEOPATHIC CHILDRENS KIT kit
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Contains inactivated NDC Code(s)
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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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 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
- INDICATIONS
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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
- INACTIVE INGREDIENTS
- STORAGE
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RXHOMEO HOMEOPATHIC CHILDRENS KIT
rxhomeo homeopathic childrens kit kitProduct 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 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 pelletProduct 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 tabletProduct 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 gelProduct 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)
