FLORA Q2- lactobacillus acidophilus capsule

Flora Q2 by

Drug Labeling and Warnings

Flora Q2 by is a Other medication manufactured, distributed, or labeled by PharmaDerm A division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

FloraQ®2

Unique Blend
of Probiotic Strains

Dietary Supplement

Gluten Free

PharmaDerm®

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Bottle Label

List 10337-001-30

30 Capsules

Double Strength

FloraQ®2

Unique Blend
of Probiotic Strains

Dietary Supplement

Gluten Free

PharmaDerm®

INGREDIENTS AND APPEARANCE

FLORA Q2 
lactobacillus acidophilus capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:10337-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
lactobacillus acidophilus (UNII: 1PRR1V42V5) (lactobacillus acidophilus - UNII:1PRR1V42V5)	lactobacillus acidophilus	16000000000 [CFU]

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:10337-001-30	1 in 1 CARTON
1		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		08/01/2007

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	16 mm
scoring	2
imprint

Labeler - PharmaDerm A division of Fougera Pharmaceuticals Inc. (043838424)