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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E), INULIN (UNII: JOS53KRJ01) (INULIN - UNII:JOS53KRJ01), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)

Διαθέσιμο από:

Solubiomix, LLC

Οδός χορήγησης:

ORAL

Περίληψη προϊόντος:

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)

Καθεστώς αδειοδότησης:

Dietary Supplement

Αρχείο Π.Χ.Π.

XYBIOTIC PROBIOTIC SUPPORT- BACILLUS COAGULANS, LACTOBACILLUS
ACIDOPHILUS
AND FIBER CAPSULE
SOLUBIOMIX, LLC
----------
XYBIOTIC
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
sup