FloraChew - Blue Heron Pharmaceuticals, LLC

Manufacturer
Blue Heron Pharmaceuticals, LLC
Effective date
2026-11-05
Label type
DIETARY SUPPLEMENT
Version
2
Source
daily-update
Hydrated at
2026-11-07 03:03:14

Label at a glance#

ProductFloraChew
Active ingredientLACTICASEIBACILLUS RHAMNOSUS
Label structure7 sections

Label contents#

Full prescribing information#

Supplement Facts

HEALTH CLAIM SECTION

FloraChew Tablets

Dispensed by Prescription

Supp FactsSupp Facts

Description:

STATEMENT OF IDENTITY SECTION

FloraChew Chewable Probiotic Tablets are white, round tablets dispensed in plastic bottles of 30 ct.

85622-0133-30

Reserved for Professional Recommendation

FloraChew Chewable Probiotic Tablets should be administered under the supervision of a licensed medical practitioner.

FloraChew Chewable Probiotic Tablets are an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

Blue Heron Pharmaceuticals

New Port Richey, FL 34652

Warnings:

WARNINGS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

FloraChew Chewable Probiotic Tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage:

DOSAGE & ADMINISTRATION SECTION

Usual dosage is 4 tablets once daily, or as recommended by your healthcare professional.

Packaging:

PRECAUTIONS SECTION

CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Storage:

SAFE HANDLING WARNING SECTION

Store at 20° - 25° C (68° - 77° F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]

Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85622-13385622-133-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LACTICASEIBACILLUS RHAMNOSUS9601IVB87JACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-09-29daily-update2026-10-01 14:01:51

Reported adverse events (FAERS/openFDA)#

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