Label: ZELAC PROBIOTIC SUPPORT- lactobacillus acidophilus and bifidobacterium animalis lactis capsule

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

Drug Label Information

Updated February 20, 2023

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 CapsuleServings per container: 30
    Amount Per Serving:%DV
    *
    Daily Values (DV) not established.
    Lactobacillus Acidophilus8 Billion*
    Bifidobacterium Lactis7.5 Billion*

    OTHER INGREDIENTS: Gelatin, Microcrystalline Cellulose, Maltodextrin, Magnesium Stearate, Silica.

  • Description 

    ZELAC capsules is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required, and maintenance of good health is needed.

  • Warnings and Precautions

    ZELAC capsules should only be used under the directions 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 other medications.

    KEEP OUT OF REACH OF CHILDREN

  • Dosage and Administration

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

  • Precautions

    Tamper Evident:  Do not use if seal is broken or missing.

    Dispensed by Prescription

  • Storage and Handling

    Store at 20°-25°C (68° -77°F); excursions permitted to 15°-30°C (59°- 86°F) [See USP Controlled Room Temperature].

    Protect from heat, light and moisture.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ZELAC   PROBIOTIC SUPPORT
    lactobacillus acidophilus and bifidobacterium animalis lactis capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69067-070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS8000000000 [CFU]
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS7500000000 [CFU]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69067-070-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/23/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    scoring1
    shape
    size (solid drugs)19 mm
    color
    Labeler - Foxland Pharmaceuticals, Inc. (079407828)
    Registrant - Foxland Pharmaceuticals, Inc. (079407828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulation Technology Incorporated062525910manufacture
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