Label: PROBICHEW PROBIOTIC SUPPORT- bacillus coagulans and fiber bar, chewable

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

Drug Label Information

Updated January 6, 2020

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

  • STATEMENT OF IDENTITY

    PROBICHEW Dietary Supplemement

    Dispensed by Prescription

     Amount Per Serving: %DV

    Bacillus Coagulans
     21 Billion *
     Dietary Fiber (as Inulin) 1 gram 4%
       *Daily Values (DV) not established

    image description

    OTHER INGREDIENTS: Sodium, Potassium, Calcium, Sugar Alcohol, Maltitol Syrup, Inulin, Palm Oil, Gum Arabic, Mono and Diglycerides, Sunflower Lecithin, Sea Salt, Natural Flavor, Stevia Extract, Whey Protein Isolate

    PROBICHEW 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.

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

    PROBICHEW 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 chew once or twice daily, or as prescribed by a licensed medical practitioner.

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

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

    DIRECTIONS FOR USE:  REMOVE FOIL BEFORE CONSUMING CHEW.  Consume entire chew or as directed by a healthcare professional.

  • SAFE HANDLING

    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

    Chews are beige in color and individually wrapped in a bronze and silver foil.

    Bottles contain 30 Chews 69597-350-30*

    Manufactured in USA for:
    Basiem, LLC

    Madisonville, LA  70447

    Rev. 12/2019

    *Basiem 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.

  • PRINCIPAL DISPLAY PANEL - 30 Chew Bottle Label

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

  • INGREDIENTS AND APPEARANCE
    PROBICHEW  PROBIOTIC SUPPORT
    bacillus coagulans and fiber bar, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69597-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E) BACILLUS COAGULANS21000000000 [CFU]
    INULIN (UNII: JOS53KRJ01) (INULIN - UNII:JOS53KRJ01) INULIN1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTITOL (UNII: D65DG142WK)  
    PALM OIL (UNII: 5QUO05548Z)  
    ACACIA (UNII: 5C5403N26O)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    SEA SALT (UNII: 87GE52P74G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    WHEY PROTEIN HYDROLYSATE (UNII: 237DZG2JLA)  
    SODIUM (UNII: 9NEZ333N27)  
    POTASSIUM (UNII: RWP5GA015D)  
    CALCIUM (UNII: SY7Q814VUP)  
    MANNITOL (UNII: 3OWL53L36A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69597-352-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/06/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    scoring1
    shape
    size (solid drugs)28 mm
    flavor
    color
    Labeler - Basiem, LLC (079686680)