Iris versicolor 6C

Manufacturer
Boiron | Boiron, Inc.
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:31

Label at a glance#

ProductIris versicolor
Active ingredientIRIS VERSICOLOR ROOT
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each pellet)

Iris versicolor 6C HPUS (0.44 mg)

The letters “HPUS” indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Iris versicolor 6C HPUS (0.44 mg)……………………Relieves minor headache pain which may be accompanied by heartburn and sour stomach

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves minor headache pain which may be accompanied by:

▪ sour stomach ▪ heartburn

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days, worsen, or new symptoms occur because these could be signs of a serious condition. If you have trouble swallowing or persistent abdominal pain, see your doctor promptly.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

lactose, sucrose

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Children under 12 years of age: Ask a doctor.

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

retain carton for full drug facts

HEADACHE PAIN*
With Heartburn ▪ Sour Stomach

1 TUBE
APPROX. 80 PELLETS

3 TUBES

APPROX. 80 PELLETS EACH

TOTAL 240 PELLETS

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073


How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.


*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-2693-412023-11-13C16284748780-1f386c64a-3d1a-0266-e053-dadaa90a7c1aIris versicolor 6C
0220-2693-412023-01-30C16284748780-1f386c64a-3d1a-0266-e053-dadaa90a7c1aIris versicolor 6C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2693-41Iris versicolor6 [hp_C] in 1 TUBEPELLET63
0220-2693-43Iris versicolor3 in 1 CARTONPELLET33

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-26930220-2693-41, 0220-2693-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Iris versicolorIRIS VERSICOLOR ROOTBoiron85cec3a4-c6fb-bcaf-e053-2a91aa0a7ef62026-05-07Exact identifier
ndc (package): 0220-2693-41
ndc (package): 0220-2693-43
ndc (product): 0220-2693
ndc11 (package): 00220269343
ndc11 (package): 00220269341
spl id: 513c4cd4-589e-400a-e063-6394a90ad2ec
spl set id: 85cec3a4-c6fb-bcaf-e053-2a91aa0a7ef6

Reported adverse events (FAERS/openFDA)#

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