FDA.reportPublic FDA data

ANTI-H.PYLORI FORMULA

Manufacturer
Bispit Canada Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:27:49

Label at a glance#

ProductANTI-H.PYLORI FORMULA
Active ingredientOPHIOPOGON JAPONICUS WHOLE, YEAST, FU LING, REISHI
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Reishi, Yeast, Fu lingOphiopogon japonicus whole.

INACTIVE INGREDIENT SECTION

Inactive ingredient: Maltodextrin, Heavy calciumcarbonate, Povidone K30.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Storage: Store in a tightly sealed container in acool, dry place,Keep out of children

OTC - PURPOSE SECTION

INHIBITING BACTERIAL GROWTH
AND PROMOTING METABOLIC EXCRETION

WARNINGS SECTION

1. This product can be taken for an extended periodof time, but it is not intended to substitutemedication. Seek medical advice promptly for severecases.
2. Avoid spicy and irritating foods for the first 3 daysof administering this product.3. Pregnant women and individuals with allergiesshould use this product only under the guidance of aphysician.

DOSAGE & ADMINISTRATION SECTION

Dosage: 3 capsules each time, twice a day(morning and evening)

INDICATIONS & USAGE SECTION

Avoid spicy and irritating foods for the first 3 daysf administering this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
YEAST Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128489714832006285631-016-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85631-016-01ANTI-H.PYLORI FORMULA0.8 g in 1 CAPSULECAPSULE0.81
85631-016-01ANTI-H.PYLORI FORMULA90 in 1 BOTTLECAPSULE901

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85631-01685631-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
OPHIOPOGON JAPONICUS WHOLE2983RA66TSACTIB
YEAST3NY3SM6B8UACTIB
FU LINGXH37TWY5O4ACTIB
CALCIUM CARBONATEH0G9379FGKIACT
REISHITKD8LH0X2ZACTIB
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONE K30U725QWY32XIACT

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
ANTI-H.PYLORI FORMULAREISHI YEAST FU LING OPHIOPOGON JAPONICUS WHOLEBispit Canada Ltd.468a15c7-c6f8-ed82-e063-6294a90a55202025-12-22WarningsExact identifier
ndc (package): 85631-016-01
ndc (product): 85631-016
ndc11 (package): 85631001601
spl id: 468a15c7-c6f9-ed82-e063-6294a90a5520
spl set id: 468a15c7-c6f8-ed82-e063-6294a90a5520

Reported adverse events (FAERS/openFDA)#

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