Label: XYBIOTIC PROBIOTIC SUPPORT- bacillus coagulans, lactobacillus acidophilus and fiber capsule
- NHRIC Code(s): 69499-352-30
- Packager: Solubiomix, LLC
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated October 3, 2023
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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
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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
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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:
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INGREDIENTS AND APPEARANCE
XYBIOTIC PROBIOTIC SUPPORT
bacillus coagulans, lactobacillus acidophilus and fiber capsuleProduct 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)