BACILLEX- probiotic capsule

Bacillex by

Drug Labeling and Warnings

Bacillex by is a Other medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Bacillex™

Serving Size: 1 Capsule

Servings Per Container: 30

Amount Per Serving:

Proprietary Blend: 10 billion CFU (Colony Forming Units)
Lactobacillus acidophilus L59: Identified as the specific strain included in the blend

Other Ingredients: Magnesium Stearate, Microcrystalline Cellulose (MCC), Vegetable Capsule (HPMC).

Dosage & Administrationz:

Usual Adult dose is one capsule daily, or as prescribed by a licensed healthcare practitioner. If you are pregnant or nursing, consult a licensed healthcare practitioner before use.

SAFE HANDLING

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

Bacillex™ should be administered under the supervision of a licensed healthcare practitioner, especially if pregnant, nursing, or under medical care.

†These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Do not use if bottle seal is broken.

STORAGE

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Keep in a cool dry place.

HOW SUPPLIED HEALTH CLAIM

Bacillex™, Probiotic

Dietary Supplement

NHRIC: 59088-019-54 *

Bottles contain 30 Capsules

Distributed in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

*Does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

Bacillex™

INGREDIENTS AND APPEARANCE

BACILLEX 
probiotic capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:59088-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	10000000000 [CFU]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:59088-019-54	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		06/26/2025

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

Labeler - PureTek Corporation (785961046)