FDA.reportPublic FDA data

VIPERA BERUS

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:25:18

Label at a glance#

ProductVIPERA BERUS
Active ingredientVIPERA BERUS VENOM
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Vipera berus 200CK

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

INDICATIONS & USAGE SECTION

Relieves painful legs improved by elevation *

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
0220-5275-41VIPERA BERUS200 [kp_C] in 1 TUBEPELLET2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-5275VIPERA BERUS (VIPERA BERUS VENOM) PELLET [BOIRON]1Current NDC, 1 package rows20240101_0c070987-c604-7b3b-e063-6294a90ad9de.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
0220-52750220-5275-41

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
SUCROSEC151H8M554IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
VIPERA BERUS VENOM0ORO6NCA4MACTIB

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
VIPERA BERUSVIPERA BERUS VENOMBoiron0c070987-c604-7b3b-e063-6294a90ad9de2023-12-08Exact identifier
ndc (package): 0220-5275-41
ndc (product): 0220-5275
ndc11 (package): 00220527541
spl id: 0c070987-c605-7b3b-e063-6294a90ad9de
spl set id: 0c070987-c604-7b3b-e063-6294a90ad9de

Reported adverse events (FAERS/openFDA)#

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