FOLTABS 800- folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

Foltabs 800 by

Drug Labeling and Warnings

Foltabs 800 by is a Other medication manufactured, distributed, or labeled by H2-Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size 1 Tablet	Servings Per Container 60
Amount Per Serving	% Daily Value
Vitamin B-6 (as pyridoxine hydrochloride)	10 mg	500%
Folic Acid	800 mcg	200%
Vitamin B-12 (as cyanocobalamin)	115 mcg	1917%

Other Ingredients: Microcrystalline cellulose, dicalcium phosphate, stearic acid, croscarmellose sodium, silica, magnesium stearate.

Coating Ingredients: Hypromellose, polydextrose, titanium dioxide, D&C yellow #10 aluminum lake, triacetin, FD&C blue #1 aluminum lake, polyethylene glycol, FD&C yellow #6 aluminum lake.

Directions

Take one tablet daily.

SAFE HANDLING WARNING

KEEP OUT OF REACH OF CHILDREN.

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

HEALTH CLAIM

Store in a cool, dry place. Protect contents from light and moisture.

HEALTH CLAIM

Rev. 09/16

H2 pharma

Manufactured for: H2-Pharma, LLC
2010 Berry Chase Place
Montgomery, AL 36117
www.h2-pharma.com

PRINCIPAL DISPLAY PANEL - 800 mcg/10 mg/115 mcg Tablet Bottle Carton

61269-325-60

Folic Acid Combination

FOLTABS®
800

Folic Acid 800 mcg,
Vitamin B-6 10 mg,
Vitamin B-12 115 mcg

DIETARY SUPPLEMENT

H2 pharma

60 TABLETS

INGREDIENTS AND APPEARANCE

FOLTABS 800 
folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:61269-325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	800 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	115 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TRIACETIN (UNII: XHX3C3X673)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:61269-325-60	1 in 1 CARTON
1		60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		10/31/2016

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	2
shape
size (solid drugs)	8 mm
imprint

Labeler - H2-Pharma, LLC (028473634)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		048488621	MANUFACTURE