Caulophyllum thalictroides 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 02:38:30

Label at a glance#

ProductCaulophyllum thalictroides
Active ingredientCAULOPHYLLUM THALICTROIDES ROOT
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each pellet)

Caulophyllum thalictroides 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*

Caulophyllum thalictroides 6C HPUS (0.44 mg)…………….…Relieves menstrual cramps

INDICATIONS & USAGE SECTION

Uses*

temporarily relives minor aches and pains associated with premenstrual and menstrual cramps

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or If redness or swelling is present.

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

MENSTRUAL CRAMP RELIEF*

Spasmodic Pain ▪ Discomfort*

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

labellabel

labellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1204-412023-02-20C16284748780-1f386c64a-27fb-0266-e053-dadaa90a7c1aCaulophyllum thalictroides 6C
0220-1204-412023-01-30C16284748780-1f386c64a-27fb-0266-e053-dadaa90a7c1aCaulophyllum thalictroides 6C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1204-41Caulophyllum thalictroides6 [hp_C] in 1 TUBEPELLET63
0220-1204-43Caulophyllum thalictroides3 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
0220-12040220-1204-41, 0220-1204-43

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
Caulophyllum thalictroidesCAULOPHYLLUM THALICTROIDES ROOTBoiron84af0590-db39-2b23-e053-2a91aa0a89c02026-05-07Exact identifier
ndc (package): 0220-1204-43
ndc (package): 0220-1204-41
ndc (product): 0220-1204
ndc11 (package): 00220120441
ndc11 (package): 00220120443
spl id: 513d524d-d0e8-794b-e063-6294a90a6dbe
spl set id: 84af0590-db39-2b23-e053-2a91aa0a89c0

Reported adverse events (FAERS/openFDA)#

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