Flora Q2

Manufacturer: PharmaDerm A division of Fougera Pharmaceuticals Inc.
Effective date: 2012-05-07
Label type: DIETARY SUPPLEMENT
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:47:28

Label at a glance#

ProductFlora Q2

Active ingredientlactobacillus acidophilus

Label structure7 sections

Contacts and useful links#

Websitewww.pharmaderm.com

www.pharmaderm.com

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 SECTION

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

THE PROBIOTIC SPECIES IN FLORA^•Q^®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 SECTION

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 SECTION

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

SAFE HANDLING WARNING SECTION

HOW SUPPLIED: Off-white capsules imprinted Flora ^• Q ^®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

PACKAGE LABEL.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^®

PACKAGE 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^®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10337-001-30	Flora Q2	30 in 1 BOTTLE	CAPSULE	30		1
10337-001-30	Flora Q2	1 in 1 CARTON	CAPSULE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10337-001	FLORA Q2 (LACTOBACILLUS ACIDOPHILUS) CAPSULE [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	1	2 package rows	20120508_5ef6a80c-4787-4ef0-8b8d-2a2c3ff60249.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10337-001-30	EA - Each	10337-001	dccbd682-3618-4ffd-b7fb-7feecb2b327e	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
lactobacillus acidophilus	ACTIVE INGREDIENT	1PRR1V42V5	1
lactobacillus acidophilus	ACTIVE MOIETY	1PRR1V42V5	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium alginate	INACTIVE INGREDIENT	C269C4G2ZQ	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Flora Q2
lactobacillus acidophilus
maltodextrin
hypromelloses
cellulose, microcrystalline
sodium alginate
silicon dioxide
magnesium stearate
titanium dioxide
FD&C BLUE NO. 2

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10337-001	10337-001-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
lactobacillus acidophilus	1PRR1V42V5	ACTIB
maltodextrin	7CVR7L4A2D	IACT
hypromelloses	3NXW29V3WO	IACT
cellulose, microcrystalline	OP1R32D61U	IACT
sodium alginate	C269C4G2ZQ	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
magnesium stearate	70097M6I30	IACT
titanium dioxide	15FIX9V2JP	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 217 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sodium alginate	SODIUM ALGINATE	C269C4G2ZQ	TABLET, EXTENDED RELEASE / ORAL		627 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
sodium alginate	SODIUM ALGINATE	C269C4G2ZQ	SUSPENSION / ORAL		49 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
sodium alginate	SODIUM ALGINATE	C269C4G2ZQ	LOZENGE / ORAL		1274 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.