Pulmonary Nodule

Manufacturer
Bispit Canada Ltd.
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:37:17

Label at a glance#

ProductPulmonary Nodule
Active ingredientEPIGALLOCATECHIN GALLATE, PLATYCODON GRANDIFLORUS WHOLE, ASTRAGALUS GUMMIFER ROOT, STYPHNOLOBIUM JAPONICUM FLOWER BUD, FRITILLARIA THUNBERGII WHOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

STYPHNOLOBIUM JAPONICUM FLOWER BUD
EPIGALLOCATECHIN GALLATE
ASTRAGALUS GUMMIFER ROOT
FRITILLARIA THUNBERGII WHOLE
PLATYCODON GRANDIFLORUS WHOLE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Store properly and out of reach of children.

OTC - PURPOSE SECTION

This product is formulated to help peopleprevent and improve symptoms of lungnodules.

INDICATIONS & USAGE SECTION

Suitable for:◆Healthy adults who are concerned aboutrespiratory health;◆Long-term smokers, those exposed tosecond-hand smoke, and people who arelong exposed to dust, harmful gases, andcooking fumes;People with lung problems such as coughsthose with sensitive respiratory systemsthose susceptible to viral infections, andthose with poor immunity

INACTIVE INGREDIENT SECTION

CALCIUM CARBONATE
CARBOXYMETHYLCELLULOSE SODIUM

WARNINGS SECTION

This product is not a substitute formedication.For severe lung diseases such aslung cancer, pulmonary fibrosis, and severepneumonia, please follow your doctor'sadvice:Not recommended for pregnant women,breastfeeding women, infants, and children;Not recommended for those allergic to theproduct's ingredients;

DOSAGE & ADMINISTRATION SECTION

Dosage: For prevention: once per day,2tablets per dosing.Patient with nodule: twice per day, 2 tabletsper dosing (doubled for severe patient).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850066597279GTIN-13: 0850066597279
EAN-13: 0850066597279
GTIN-12: 850066597279
UPC-A: 850066597279
GTIN storage (14 digits): 00850066597279
85631-011-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85631-011-01Pulmonary Nodule60 in 1 BOTTLECAPSULE601
85631-011-01Pulmonary Nodule1 g in 1 CAPSULECAPSULE11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85631-01185631-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Pulmonary NodulePULMONARY NODULEBispit Canada Ltd.42af8bf8-80b4-e1a1-e063-6394a90a306c2025-11-03WarningsExact identifier
ndc (package): 85631-011-01
ndc (product): 85631-011
ndc11 (package): 85631001101
spl id: 42af8bf8-80b5-e1a1-e063-6394a90a306c
spl set id: 42af8bf8-80b4-e1a1-e063-6394a90a306c

Reported adverse events (FAERS/openFDA)#

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