Label: BILAC- lactobacillus acidophilus,bifidobacterium animalis lactis capsule

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

Drug Label Information

Updated March 6, 2023

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  • Statement of identity

    Bilac 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.

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

  • Warning

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

    Bilac should be administered under the 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 THIS OUT OF THE REACH OF CHILDREN.

  • Dosage and administration

    Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

  • Safe handling and warning

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

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    BILAC 
    lactobacillus acidophilus,bifidobacterium animalis lactis capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:82793-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS17000000000 [CFU]
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS16000000000 [CFU]
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:82793-001-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement07/01/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    shape
    size (solid drugs)21 mm
    scoring1
    color
    Labeler - Wellness Pharma, LLC (117792876)
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