FDA.reportPublic FDA data

Aristolochia clematitis

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:28:18

Label at a glance#

ProductAristolochia clematitis
Active ingredientARISTOLOCHIA CLEMATITIS ROOT
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aristolochia clematitis 200CK HPUS

Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

INDICATIONS & USAGE SECTION

Relieves premenstrual syndrome *

Uses: See symptoms on front panel.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

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.

DOSAGE & ADMINISTRATION SECTION

Adults and children: 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.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com Info@boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
Contains approx.80 pellets.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0538-41Aristolochia clematitis200 [kp_C] in 1 TUBEPELLET2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-0538ARISTOLOCHIA CLEMATITIS (ARISTOLOCHIA CLEMATITIS ROOT) PELLET [BOIRON]1Current NDC, 1 package rows20241023_24fdac89-9d40-eec2-e063-6394a90aff54.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-05380220-0538-41

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ARISTOLOCHIA CLEMATITIS ROOTZY0NX0W00DACTIB
LACTOSEJ2B2A4N98GIACT
SUCROSEC151H8M554IACT

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
Aristolochia clematitisARISTOLOCHIA CLEMATITIS ROOTBoiron24fdac89-9d40-eec2-e063-6394a90aff542024-10-21Exact identifier
ndc (package): 0220-0538-41
ndc (product): 0220-0538
ndc11 (package): 00220053841
spl id: 24fdac89-9d41-eec2-e063-6394a90aff54
spl set id: 24fdac89-9d40-eec2-e063-6394a90aff54

Reported adverse events (FAERS/openFDA)#

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