Label: BACICAP PROBIOTIC- proprietary blend of probiotic bacteria capsule

  • NHRIC Code(s): 72678-019-01
  • Packager: NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated June 20, 2020

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

  • STATEMENT OF IDENTITY

    BACICAP Probiotic Dietary Supplement

    Dispensed by Prescription

     Amount Per Serving

     %DV

    Proprietary blend of Probiotic Bacteria;

    MAKTREK (Bi-Pass Technology)

     20 Billion

     *

       *Daily Values (DV) not established

    image description

    OTHER INGREDIENTS: Cellulose (Vegetable Capsule), Rice Maltodextrin, L-Leucine

    BACICAP is an orally administered prescription probiotic 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.

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

    BACICAP 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.

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

    DIRECTIONS FOR USE: Take as directed by a healthcare professional.

  • SAFE HANDLING

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

    BACICAP capsules 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

    BACICAP, Probiotic Dietary Supplement

    Capsules are off-white in color, each bottle contains 30 Capsules 72678-019-01*

    Manufactured in USA for:
    NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY
    Branchburg, NJ 08876
    Rev. 3/2020

    * NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY 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 CAPSULES BOTTLE LABEL

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  • INGREDIENTS AND APPEARANCE
    BACICAP PROBIOTIC 
    proprietary blend of probiotic bacteria capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72678-019
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS20000000000 [CFU]
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS20000000000 [CFU]
    LACTOBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTOBACILLUS PLANTARUM - UNII:QFC21096ON) LACTOBACILLUS PLANTARUM20000000000 [CFU]
    LACTOBACILLUS PARACASEI (UNII: N1G291SC6Q) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J) LACTOBACILLUS PARACASEI20000000000 [CFU]
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-CELLULOSE (UNII: I355QGZ19A)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ACETYLLEUCINE, L- (UNII: E915HL7K2O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72678-019-0130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/20/2020
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)22 mm
    scoring1
    Labeler - NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY (967054623)