Flora Q description, usages, side effects, indications, overdosage, supplying and lots more!

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Flora Q

PharmaDerm a division of Fougera Pharmaceuticals Inc.

Flora•Q Dietary Supplement Gluten FreeBRAND NAME: Flora•Q




FULL PRESCRIBING INFORMATION

PRODUCT DESCRIPTION: Off-white capsules, each containing 180 mg* of a standardized, light-beige colored powder consisting of an aggregate of a minimum of 8 billion CFU (8 x 109 Colony Forming Units) freeze-dried cultures at time of manufacture of species listed below.

Guaranteed potency of no less than 4 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 230 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

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

THE PROBIOTIC SPECIES IN FLORA Q ®:

  • 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.

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.

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

HOW SUPPLIED: Off-white capsules imprinted Flora Q ® are supplied in bottles of 30 (List 10337-400-30).

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

IL195B R11/11

Principal Display Panel – Carton Label

List 10337-400-30

30
Capsules

Flora•Q®

Unique Blend
of Probiotic Strains

Dietary Supplement

Gluten Free

PharmaDerm®

Principal Display Panel – Bottle Label

List 10337-400-30

30 Capsules

Flora•Q®

Unique Blend
of Probiotic Strains

Dietary Supplement

Gluten Free

PharmaDerm®

Flora Q

lactobacillus acidophilus CAPSULE

Product Information

Product Type Dietary supplement Item Code (Source) NDC:10337-400
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS 8000000000 [CFU]

Inactive Ingredients

Ingredient Name Strength
maltodextrin
HYPROMELLOSES
cellulose, microcrystalline
SODIUM ALGINATE
SILICON DIOXIDE
MAGNESIUM STEARATE
titanium dioxide
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
white (WHITE) 16 mm Flora;Q; OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:10337-400-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2004-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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