HARPAGOPHYTUM

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:14

Label at a glance#

ProductHARPAGOPHYTUM
Active ingredientHARPAGOPHYTUM PROCUMBENS ROOT
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient** (in each pellet)

Harpagophytum 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*

Harpagophytum 6C HPUS (0.44 mg) ... Relieves minor aches and pain associated with arthritis

INDICATIONS & USAGE SECTION

Uses*

Tube - Minor aches and pains associated with arthritis*

Box - temporarily relieves discomfort, stiffness, and minor pain due to arthritis

OTC - STOP USE SECTION

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

Box - Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

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

Tube - Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions

Tube - 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.

Box - 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. If pain increases, take every 2 hours, up to 8 times a day.

Children under 12 years of age: Ask a doctor

SPL UNCLASSIFIED SECTION

Tube - 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.

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

contains 0.25 g of sugar per dose

Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue

Meltaway pellets

16 DOSES PER TUBE

3 TUBES

Approx. 80 pellets each

Total 240 pellets

Arthritis Pain Relief*

Pain Stiffness Discomfort*

*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.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelLabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2374-41HARPAGOPHYTUM6 [hp_C] in 1 TUBEPELLET63
0220-2374-43HARPAGOPHYTUM6 [hp_C] in 1 TUBEPELLET63
0220-2374-43HARPAGOPHYTUM3 in 1 BOXPELLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-2374HARPAGOPHYTUM (HARPAGOPHYTUM PROCUMBENS ROOT) PELLET [BOIRON]3Current NDC, Legacy NDC, 3 package rows20231222_b9819b1b-c541-970d-e053-2995a90a64ed.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
0220-23740220-2374-41, 0220-2374-43

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
HARPAGOPHYTUMHARPAGOPHYTUM PROCUMBENS ROOTBoironb9819b1b-c541-970d-e053-2995a90a64ed2023-12-21Exact identifier
ndc (package): 0220-2374-43
ndc (package): 0220-2374-41
ndc (product): 0220-2374
ndc11 (package): 00220237441
ndc11 (package): 00220237443
spl id: 0d09e624-a660-2b39-e063-6294a90a0e86
spl set id: b9819b1b-c541-970d-e053-2995a90a64ed

Reported adverse events (FAERS/openFDA)#

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