Hydrastis candadensis

Manufacturer
Boiron | Boiron, Inc. | Reed Lane, Inc.
Effective date
2023-01-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:19:46

Label at a glance#

ProductHydrastis candadensis
Active ingredientGOLDENSEAL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each pellet)

Hydrastis candadensis 6C HPUS (0.44 mg)

(contains less than 10-12 mg hydrastine and berberine alkaloids)

The letter "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Hydrastis candadensis 6C HPUS (0.44 mg) ... Relieves post-nasal drip symptoms

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves occasional symptoms of post-nasal drip such as:

  • nasal congestion
  • excess mucus
  • scratch throat

Tube - Post-Nasal Drip*

OTC - DO NOT USE SECTION

Do not use if you have a fever.

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 breastfeeding, 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.

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

3 TUBES

APPROX. 80 PELLETS EACH

TOTAL 240 PELLETS

MELTAWAY PELLETS

No Known Drug Interactions

Non-Drowsy

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Post-Nasal Drip Relief*

Excess Mucus Scratchy Throat*

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.

INACTIVE INGREDIENT SECTION

lactose, sucrose

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2551-41Hydrastis candadensis6 [hp_C] in 1 TUBEPELLET64
0220-2551-43Hydrastis candadensis3 in 1 BOXPELLET34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-2551HYDRASTIS CANDADENSIS (GOLDENSEAL) PELLET [BOIRON]4Current NDC, Legacy NDC, 2 package rows20230121_85b973a2-ca44-1384-e053-2991aa0ab260.zip

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
0220-25510220-2551-41, 0220-2551-43

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
Hydrastis candadensisGOLDENSEALBoiron85b973a2-ca44-1384-e053-2991aa0ab2602023-01-20Exact identifier
ndc (package): 0220-2551-41
ndc (package): 0220-2551-43
ndc (product): 0220-2551
ndc11 (package): 00220255143
ndc11 (package): 00220255141
spl id: f2b8e25c-5e0c-5254-e053-2a95a90ab3b1
spl set id: 85b973a2-ca44-1384-e053-2991aa0ab260

Reported adverse events (FAERS/openFDA)#

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