Label: PROVAD- bacillus subtilus capsule

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

Drug Label Information

Updated February 14, 2019

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

  • DESCRIPTION

    Provad is an orally administered prescription probiotic 

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


    PLEASE NOTE: The product label name of "30 Billion-Biotic" is a descriptive marketing name only and not intended to represent the exact contents of the capsules. The actual product contains 29.3 Billion CFU. Please refer to details below for actual ingrediants and amounts.

  • HEALTH CLAIM

    image description

  • WARNINGS AND PRECAUTIONS

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

    Provad 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.

  • DOSAGE AND ADMINISTRATION

    Usual adult dose is 1 capsule daily with or without food or as prescribed by your doctor.

    INDICATIONS AND USAGE

    Provad 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.

  • HOW SUPPLIED:

    Provad is supplied as apsules dispensed in 180cc plastic bottles of 30ct.

    69176-680-30

    Reserved for Professional Recommendation
    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
    Manufactured for and distributed by:
    TMIG INC, Marietta, GA 30062

  • STORAGE:

    Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    KEEP THIS OUT OF THE REACH OF CHILDREN.

  • PACKAGE LABEL:

    image description

    Rev2.1.19

    Item 68030

  • INGREDIENTS AND APPEARANCE
    PROVAD 
    bacillus subtilus capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69176-680
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACILLUS SUBTILIS (UNII: 8CF93KW41W) (BACILLUS SUBTILIS - UNII:8CF93KW41W) BACILLUS SUBTILIS26000000000 [CFU]
    BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E) BACILLUS COAGULANS1300000000 [CFU]
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS250000000 [CFU]
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS250000000 [CFU]
    BIFIDOBACTERIUM LONGUM (UNII: 831AQW699W) (BIFIDOBACTERIUM LONGUM - UNII:831AQW699W) BIFIDOBACTERIUM LONGUM250000000 [CFU]
    LACTOBACILLUS RHAMNOSUS (UNII: 9601IVB87J) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J) LACTOBACILLUS RHAMNOSUS250000000 [CFU]
    LACTOBACILLUS SALIVARIUS (UNII: 7A4S6N2EG2) (LACTOBACILLUS SALIVARIUS - UNII:7A4S6N2EG2) LACTOBACILLUS SALIVARIUS250000000 [CFU]
    LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI250000000 [CFU]
    BIFIDOBACTERIUM BREVE (UNII: L07O8T40TE) (BIFIDOBACTERIUM BREVE - UNII:L07O8T40TE) BIFIDOBACTERIUM BREVE250000000 [CFU]
    LACTOBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTOBACILLUS PLANTARUM - UNII:QFC21096ON) LACTOBACILLUS PLANTARUM250000000 [CFU]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69176-680-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement02/01/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)16 mm
    scoring1
    Labeler - TMIG Inc (036572986)