BIOTRELLE- acidophilus/pectin capsule

BIOTRELLE by

Drug Labeling and Warnings

BIOTRELLE by is a Other medication manufactured, distributed, or labeled by Blue Heron Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM:

Biotrelle Probiotic Capsules

Dispensed by Prescription   

DESCRIPTION:

Biotrelle Probiotic Capsules are clear capsules dispensed in plastic bottles of 30 ct.

85622-0107-30

Reserved for Professional Recommendation

Biotrelle Probiotic Capsules should be administered under the supervision of a licensed medical practitioner.

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

Lutz, FL 33559

WARNINGS:

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

As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.

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 AND ADMINISTRATION:

Usual adult dose is 2 capsules by mouth daily once daily, or as prescribed by a licensed medical practitioner.

Biotrelle is 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.

PRECAUTIONS:

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:

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

PACKAGING:

INGREDIENTS AND APPEARANCE

BIOTRELLE 
acidophilus/pectin capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:85622-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	200000000 [CFU]
DICALCIUM PHOSPHATE (UNII: L11K75P92J) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	DICALCIUM PHOSPHATE	304 mg
PECTIN, CITRUS (UNII: 47EQO8LE7H) (PECTIN - UNII:89NA02M4RX)	PECTIN, CITRUS	20 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:85622-107-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		11/13/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	25 mm
scoring	1

Labeler - Blue Heron Pharmaceuticals, LLC (137019051)