Rxhomeo Homeopathic Childrens Kit
FDA Label NDC 15631-2452

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rxhomeo Private Limited D.b.a. for the product Rxhomeo Homeopathic Childrens Kit (NDC 15631-2452). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, indications, dosage, warnings, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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

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.

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

This product is to be used for self-limiting conditions

Otc - Stop Use

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

Keep this and all medication out of reach of children

Otc - Do Not Use

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 | [email protected]
Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

Package Label.Principal Display Panel

Image Description (15631 2452 4)

Image Description (15631 2452 4)

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