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

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 3, 2023

If you are a consumer or patient please visit this version.

  • 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:

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

  • INGREDIENTS AND APPEARANCE
    XYBIOTIC  PROBIOTIC SUPPORT
    bacillus coagulans, lactobacillus acidophilus and fiber capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69499-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E) BACILLUS COAGULANS220 mg
    INULIN (UNII: JOS53KRJ01) (INULIN - UNII:JOS53KRJ01) INULIN25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS220 mg
    Inactive Ingredients
    Ingredient NameStrength
    WHEY (UNII: 8617Z5FMF6)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69499-352-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/25/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    scoring1
    shape
    size (solid drugs)22 mm
    color
    Labeler - Solubiomix, LLC (079640556)