FDA.reportPublic FDA data

Rxhomeo Homeopathic Childrens Kit

Manufacturer
Rxhomeo Private Limited d.b.a.
Effective date
2016-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:07

Label at a glance#

ProductRxhomeo Homeopathic Childrens Kit
Active ingredientACONITUM NAPELLUS, ONION, ANTIMONY POTASSIUM TARTRATE, APIS MELLIFERA, ARSENIC TRIOXIDE, ARNICA MONTANA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, HYPERICUM PERFORATUM, IPECAC, MERCURIUS SOLUBILIS, STRYCHNOS NUX-VOMICA SEED, PODOPHYLLUM, TOXICODENDRON PUBESCENS LEAF, FERROSOFERRIC PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Indications and 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 ...

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.
Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose for Pellets.

Aloe Vera Gel for Ointment

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

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 descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-2452-42020-01-31C16284748780-19d75b9d1-1d3a-f424-e053-dadaa90a57ceadc87f76-9674-4759-a767-a5a1a85cb61b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-2452-4Rxhomeo Homeopathic Childrens Kit1 in 1 CONTAINERKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-2452RXHOMEO HOMEOPATHIC CHILDRENS KIT KIT [RXHOMEO PRIVATE LIMITED D.B.A.]1Legacy NDC, 1 package rows20160803_adc87f76-9674-4759-a767-a5a1a85cb61b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15631-245215631-2452-4
15631-0005
15631-0015
15631-0038
15631-0039
15631-0050
15631-0049
15631-0076
15631-0087
15631-0123
15631-0184
15631-0589
15631-0207
15631-0229
15631-0237
15631-0295
15631-0317
15631-0354
15631-0374
15631-0584
15631-2310

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
SUCROSEC151H8M554IACT
ONION492225Q21HACTIB
SUCROSEC151H8M554IACT
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
SUCROSEC151H8M554IACT
APIS MELLIFERA7S82P3R43ZACTIB
SUCROSEC151H8M554IACT
ARSENIC TRIOXIDES7V92P67HOACTIB
SUCROSEC151H8M554IACT
ARNICA MONTANAO80TY208ZWACTIB
SUCROSEC151H8M554IACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SUCROSEC151H8M554IACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
SUCROSEC151H8M554IACT
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
SUCROSEC151H8M554IACT
EUPHRASIA STRICTAC9642I91WLACTIB
SUCROSEC151H8M554IACT
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
SUCROSEC151H8M554IACT
NITROGLYCERING59M7S0WS3ACTIB
SUCROSEC151H8M554IACT
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
SUCROSEC151H8M554IACT
IPECAC62I3C8233LACTIB
SUCROSEC151H8M554IACT
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SUCROSEC151H8M554IACT
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SUCROSEC151H8M554IACT
PODOPHYLLUM2S713A4VP3ACTIB
SUCROSEC151H8M554IACT
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SUCROSEC151H8M554IACT
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
LACTOSEJ2B2A4N98GIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ALOEV5VD430YW9IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLONOINUMGLONOINUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc6997b44a-4caf-4e2f-a930-50eb719453552021-10-11WarningsExact identifier
ndc (product): 15631-0207
EUPHRASIA OFFICINALISEUPHRASIA OFFICINALISRxhomeo Private Limited d.b.a. Rxhomeo, Inc1cf52c36-a405-40a8-a492-20df572aedf22021-10-08WarningsExact identifier
ndc (product): 15631-0184
ANTIMONIUM TARTARICUMANTIMONIUM TARTARICUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc95f396ae-00f7-460f-be6a-80d0fdfaed5c2021-09-27WarningsExact identifier
ndc (product): 15631-0038
ALLIUM CEPAALLIUM CEPARxhomeo Private Limited d.b.a. Rxhomeo, Inc5652c201-6e75-495d-9f95-dfddb4497f542021-09-27WarningsExact identifier
ndc (product): 15631-0015
IPECACUANHAIPECACUANHARxhomeo Private Limited d.b.a. Rxhomeo, Inc104080d7-4de4-47c2-a7fc-9e4b0cfd030f2021-09-26WarningsExact identifier
ndc (product): 15631-0237
HYPERICUM PERFORATUMHYPERICUM PERFORATUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc1241b306-e37f-4381-9e7c-1861d1c5dae12021-09-02WarningsExact identifier
ndc (product): 15631-0229
ACONITUM NAPELLUSACONITUM NAPELLUSRxhomeo Private Limited d.b.a. Rxhomeo, Inceace2915-a54b-4649-9bd0-19461ff28dd52021-09-02WarningsExact identifier
ndc (product): 15631-0005
BRYONIA ALBABRYONIA ALBARxhomeo Private Limited d.b.a. Rxhomeo, Inc134c943f-a71d-4321-8201-cb2695374cb82021-09-02WarningsExact identifier
ndc (product): 15631-0087
MERCURIUS SOLUBILISMERCURIUS SOLUBILISRxhomeo Private Limited d.b.a. Rxhomeo, Incc812884b-0a8b-4358-ba75-c94c29193f792021-09-02WarningsExact identifier
ndc (product): 15631-0295
APIS MELLIFICAAPIS MELLIFICARxhomeo Private Limited d.b.a. Rxhomeo, Inc130b273c-ffc9-4976-938d-ae7b972d1dd42021-09-02WarningsExact identifier
ndc (product): 15631-0039
CHAMOMILLACHAMOMILLARxhomeo Private Limited d.b.a. Rxhomeo, Inc7e21364d-0617-46a7-a03c-33c4273ecc072021-09-02WarningsExact identifier
ndc (product): 15631-0123
ARNICA MONTANAARNICA MONTANARxhomeo Private Limited d.b.a. Rxhomeo, Incde6636fd-aa9a-4283-8af9-4c6520a5dfb52021-08-23WarningsExact identifier
ndc (product): 15631-0049
NUX VOMICANUX VOMICARxhomeo Private Limited d.b.a. Rxhomeo, Inc98af289f-969f-494d-8998-a5eea1c9e67e2021-08-23WarningsExact identifier
ndc (product): 15631-0317
BELLADONNABELLADONNARxhomeo Private Limited d.b.a. Rxhomeo, Incf808ba4e-4421-4bc0-a2c7-42a8db8ed2e82021-08-23WarningsExact identifier
ndc (product): 15631-0076
ARSENICUM ALBUMARSENICUM ALBUMRxhomeo Private Limited d.b.a. Rxhomeo, Ince4f05f24-6214-42f4-a76c-7d6c31ce06502021-08-23WarningsExact identifier
ndc (product): 15631-0050
RHUS TOXICODENDRONRHUS TOXICODENDRONRxhomeo Private Limited d.b.a. Rxhomeo, Inc05bf00bd-c16a-4631-9b1b-7b683749cff72021-08-16WarningsExact identifier
ndc (product): 15631-0374
f1593464-c998-4ef1-8483-5066d497d41aadc87f76-9674-4759-a767-a5a1a85cb61b2016-07-29WarningsExact identifier
spl id: f1593464-c998-4ef1-8483-5066d497d41a
spl set id: adc87f76-9674-4759-a767-a5a1a85cb61b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.