Label: WELLPRO 31- lactobacillus acidophilus and bifidobacterium animalis lactis capsule

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

Drug Label Information

Updated October 25, 2023

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  • HEALTH CLAIM

    71741-376-30
    Dietary Supplement
    Dispensed by Prescription

  • DESCRIPTION

    WellPro 31 is an orally administered prescription probiotic dietary supplement.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving size 1 Capsule
    Amount per Serving:% Daily Value
    *
    Daily value not established
    Lactobacillus Acidophilus16 Billion*
    Bifidobacterium Animalis Lactis15 Billion*

    OTHER INGREDIENTS: Modified Cellulose, Silicon Dioxide, Magnesium Stearate.

    Preservative Free and Gluten Free

  • INDICATIONS

    WellPro 31 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. WellPro 31 should be administered under the supervision of a licensed medical practitioner.

  • CONTRAINDICATIONS

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

  • WARNING

    WellPro 31 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 other medications.

  • ADVERSE REACTIONS

    You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.

  • DOSAGE AND ADMINISTRATION

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

  • HOW SUPPLIED

    Bottle of 30 capsules (71741-376-301). Capsule is off-white, oblong.

    1
    Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
  • STORAGE AND HANDLING

    Store 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place.

    TAMPER EVIDENT: Do not use if seal is broken or missing.

  • HEALTH CLAIM

    MADE IN USA

    Distributed by:

    Redmont Pharmaceuticals, LLC
    Birmingham, AL 35209
    800-986-5909

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any diseases.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    © 2023 Redmont Pharmaceuticals, LLC
    376111-1023

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    71741-376-30

    WellPro 31

    PROBIOTIC SUPPORT

    Lactobacillus Acidophilus
    Bifidobacterium Animalis Lactis
    31 Billion CFU's
    DIETARY SUPPLEMENT

    30 CAPSULES

    Dispensed by Prescription

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    WELLPRO 31 
    lactobacillus acidophilus and bifidobacterium animalis lactis capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71741-376
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lactobacillus Acidophilus (UNII: 1PRR1V42V5) (Lactobacillus Acidophilus - UNII:1PRR1V42V5) Lactobacillus Acidophilus16000000000 [CFU]
    Bifidobacterium Animalis Lactis (UNII: 5307V7XW8I) (Bifidobacterium Animalis Lactis - UNII:5307V7XW8I) Bifidobacterium Animalis Lactis15000000000 [CFU]
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71741-376-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement10/20/2023
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)23 mm
    Labeler - Redmont Pharmaceuticals, LLC (080843607)
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