Label: PRIMIDAR- lactobacillus and bifidobacterium capsule

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

Drug Label Information

Updated November 1, 2021

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

View All Sections
  • DESCRIPTION

    Primidar 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.

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

  • HEALTH CLAIM

    image description

  • WARNINGS AND PRECAUTIONS

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

    Primidar 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 dose is 1 to 2 capsule daily with or without food. Do not exceed 3 capsules per day.

  • HOW SUPPLIED:

    Primidar is supplied as clear vegetarian capsules dispensed in white HDPE plastic bottles of 30ct.
    Item 0276-0700-30

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Primidar is an orally administered prescription probiotic supplement, indicated for the distinct nutritional requirements
    of patients in need of dietary supplementation as determined by a licensed medical practitioner. Primidar should be
    administered under the supervision of a licensed medical practitioner.

    image description

  • INGREDIENTS AND APPEARANCE
    PRIMIDAR 
    lactobacillus and bifidobacterium capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0276-0700
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0276-0700-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement11/01/2021
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)16 mm
    scoring1
    Labeler - Misemer Pharmaceuticals, Inc. (784121365)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!