973171c5-5f06-4f0c-a5b5-bd8849408cba

SPL v2

SPL

SPL Set ID 973171c5-5f06-4f0c-a5b5-bd8849408cba

Route

oral

Published

Effective Date 2015-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

iris versicolor root (1 [hp_X])

Inactive Ingredients

lactose

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2015-12-18

Description

IRIS VERSICOLOR HPUS 1X and Higher

Medication Information

Warnings

This product is to be used for self-limiting conditions

Uses

Ophtalmic Migraine

Inactive Ingredients

Lactose

Description

IRIS VERSICOLOR HPUS 1X and Higher

Dosage

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.

Section 50565-1

Keep this and all medication out of reach of children

Section 50566-9

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

Section 50570-1

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 53414-9

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

Storage

Store in a cool dark place

Indications

Condition listed above or as directed by the physician

Active Ingredient

IRIS VERSICOLOR HPUS 1X and Higher

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

Structured Label Content

Warnings (WARNINGS)

This product is to be used for self-limiting conditions

Uses (USES)

Ophtalmic Migraine

Inactive Ingredients (INACTIVE INGREDIENTS)

Lactose

Dosage (DOSAGE)

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.

Section 50565-1 (50565-1)

Keep this and all medication out of reach of children

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 53414-9 (53414-9)

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

Storage (STORAGE)

Store in a cool dark place

Indications (INDICATIONS)

Condition listed above or as directed by the physician

Active Ingredient (ACTIVE INGREDIENT)

IRIS VERSICOLOR HPUS 1X and Higher

Questions Or Comments (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 (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "IRIS VERSICOLOR ROOT", "unii": "X43D4L3DQC", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "Ophtalmic Migraine", "DOSAGE": "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.", "50565-1": "Keep this and all medication out of reach of children", "50566-9": "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional", "50570-1": "Do not use if capseal is broken or missing. Close the cap tightly after use.", "53414-9": "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product", "STORAGE": "Store in a cool dark place", "WARNINGS": "This product is to be used for self-limiting conditions", "INDICATIONS": "Condition listed above or as directed by the physician", "ACTIVE INGREDIENT": "IRIS VERSICOLOR HPUS 1X and Higher", "INACTIVE INGREDIENTS": "Lactose", "QUESTIONS OR COMMENTS": "www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:32.727163 · Updated: 2026-03-14T23:14:35.871833