Label: FLORA Q2- lactobacillus acidophilus capsule

  • NHRIC Code(s): 10337-001-30
  • Packager: PharmaDerm A division of Fougera Pharmaceuticals Inc.
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated May 7, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • STATEMENT OF IDENTITY

    PRODUCT DESCRIPTION: Off-white capsules, each containing 300 mg* of a standardized, light-beige colored powder consisting of an aggregate of a minimum of 16 billion CFU (16 x 109 Colony Forming Units) freeze-dried cultures at time of manufacture of species listed below.

    Guaranteed potency of no less than 8 billion CFU freeze-dried cultures at expiration date.

    * Based on an estimated tapped density of 0.7 g/mL.

    Also contains: maltodextrin, hypromellose, microcrystalline cellulose, sodium alginate, silicon dioxide, magnesium stearate, titanium dioxide, and FD&C Blue 2.

    Each capsule, containing a proprietary probiotic blend and other ingredients, is equivalent to 375 mg per serving.

    This product is free of the following allergens: wheat/gluten, milk/lactose, eggs, fish, crustacean shellfish, soybeans, tree nuts, and peanuts.

    Contains no preservatives.

    GENERIC NAME:

    Lactobacillus acidophilus

    Bifidobacterium

    Lactobacillus paracasei

    Streptococcus thermophilus

  • HEALTH CLAIM

    COMMON USES: This probiotic is used to help maintain the normal bacterial balance of the gastrointestinal tract.

    THE PROBIOTIC SPECIES IN FLORAQ®2:

    • Help maintain balance in the intestinal microflora.
    • Support the colonization of intestinal microflora.
    • Help support the modulation of intestinal microflora.
    • Promote gastrointestinal health.
    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
  • PRECAUTIONS

    HOW TO USE: Use this product as directed on the package, unless instructed differently by your doctor.

    CAUTIONS: Before you begin taking any dietary supplement, check with your doctor or pharmacist.

    KEEP OUT OF THE REACH OF CHILDREN.

    POSSIBLE SIDE EFFECTS: Potential side effects that may dissipate include increased stomach gas. If this occurs and is bothersome, check with your doctor. Should you experience symptoms of an allergic reaction, including rash, itching, swelling, dizziness or trouble breathing, contact your doctor, nurse or pharmacist immediately.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Take one capsule per day. May be taken with or without food.

  • SAFE HANDLING WARNING

    HOW SUPPLIED: Off-white capsules imprinted FloraQ®2 are supplied in bottles of 30 (List 10337-001-30).

    STORAGE: Potency guaranteed through expiration date on package when stored at room temperature (25º C/77º F) or below. DO NOT STORE IN THE BATHROOM. Keep container closed. No refrigeration needed.

    Do not use if seal on bottle is broken or missing.

    Manufactured for:
    PharmaDerm®
    A divisdion of
    Fougera
    PHARMEUTICALS INC.
    Melville, New York 11747
    www.pharmaderm.com

    IL306B R11/11

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    List 10337-001-30

    30
    Capsules

    Double Strength

    Flora•Q®2

    Unique Blend
    of Probiotic Strains

    Dietary Supplement

    Gluten Free

    PharmaDerm®

    Principal Display Panel – Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Bottle Label

    List 10337-001-30

    30 Capsules

    Double Strength

    Flora•Q®2

    Unique Blend
    of Probiotic Strains

    Dietary Supplement

    Gluten Free

    PharmaDerm®

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    FLORA Q2 
    lactobacillus acidophilus capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10337-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    lactobacillus acidophilus (UNII: 1PRR1V42V5) (lactobacillus acidophilus - UNII:1PRR1V42V5) lactobacillus acidophilus16000000000 [CFU]
    Inactive Ingredients
    Ingredient NameStrength
    maltodextrin (UNII: 7CVR7L4A2D)  
    hypromelloses (UNII: 3NXW29V3WO)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    sodium alginate (UNII: C269C4G2ZQ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    magnesium stearate (UNII: 70097M6I30)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:10337-001-301 in 1 CARTON
    130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement08/01/2007
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)16 mm
    scoring2
    imprint
    Labeler - PharmaDerm A division of Fougera Pharmaceuticals Inc. (043838424)