XYBIOTIC PROBIOTIC SUPPORT- bacillus coagulans, lactobacillus acidophilus and fiber capsule

Xybiotic by

Drug Labeling and Warnings

Xybiotic by is a Other medication manufactured, distributed, or labeled by Solubiomix, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

XYBIOTIC Dietary Supplemement

Dispensed by Prescription 

Serving Size: 1 Capsule                                Servings per container: 30 

Amount Per Serving:		%DV
Folic Acid Probiotic Blend (Lactobacillus acidophilus 220 mg,; Bacillus Coagulans 220 mg)	1667 mcg DFE (1 mg)  15 Billion CFU	417%  *
Dietary Fiber (as Inulin)	25 mg	*
*Daily Values (DV) not established

 OTHER INGEDIENTS:  whey (milk), capsule (gelatin), magnesium stearate.  CONTAINS: Milk

Gluten Free

XYBIOTIC is an orally administered prescription probiotic/prebiotic 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.#

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

XYBIOTIC is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are “Generally Recognized as Safe” (GRAS) for their intended use.

DOSAGE

Usual adult dose is 1 capsule once or twice daily, or as prescribed by a licensed medical practitioner.

If you are pregnant or nursing, ask a healthcare professional.

XYBIOTIC should be administered under the supervision of a licensed medical practitioner.‡

SAFE HANDLING

PRECAUTIONFolic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.† XYBIOTIC Capsules should only be used under the direction and supervision of a licensed medical practitioner.‡

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

PROBICHEW chews 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.

KEEP OUT OF 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.]

HOW SUPPLIED HEALTH CLAIM

PROBICHEW, Probiotic/Prebiotic Support

Dietary Supplement

Each bottles contains 30 Capsules (white) 69499-352-30#

Manufactured in USA for:

Solubiomix, LLC

Madisonville, LA  70447

Rev. 05/2022

# Solubiomix does not represent these product codesto 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.

‡ This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only 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.
1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

PRINCIPAL DISPLAY PANEL:

INGREDIENTS AND APPEARANCE

XYBIOTIC  PROBIOTIC SUPPORT
bacillus coagulans, lactobacillus acidophilus and fiber capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69499-352
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E)	BACILLUS COAGULANS	220 mg
INULIN (UNII: JOS53KRJ01) (INULIN - UNII:JOS53KRJ01)	INULIN	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	220 mg

Inactive Ingredients
Ingredient Name	Strength
WHEY (UNII: 8617Z5FMF6)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69499-352-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/25/2022

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
scoring	1
shape
size (solid drugs)	22 mm
color

Labeler - Solubiomix, LLC (079640556)