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Drug Labeling and Warnings

Drug Details [pdf]

FABB- folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet 
Mayne Pharma Inc.

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DOSAGE AND ADMINISTRATION

Adults – one tablet daily or as directed by a physician.

Supplement Facts
Serving Size 1 Tablet Servings Per Container 100
	Amount Per Serving	%Daily Values
Vitamin B-6 (as pyridoxine HCl)	25 mg	1250%
Folic Acid	2.2 mg†	550%
Vitamin B-12 (as cyanocobalamin)	1 mg	16670%

OTHER INGREDIENTS: Calcium Carbonate, Microcrystalline Cellulose, Magnesium Stearate.

Less than 1%: Ethylcellulose, Triacetin, Di-Acetylated Monoglycerides, Macrogol/PEG, Oleic Acid.

†WARNING

This product contains a high amount of Folic Acid. Consult with a physician prior to use.

CAUTION

Do not use if you are under the age of 18. If you are taking medication, are under a health professional's care, or are pregnant or nursing consult with a physician prior to use.

KEEP OUT OF THE REACH OF CHILDREN .

Tamper Evidence feature: Do not use if seal under cap is torn, broken or missing.

*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.

STORAGE CONDITIONS

Store at controlled room temperature, 15°-30°C (59°-86°F).

Protect from light and moisture.

68308-326-10

Distributed by:
Mayne Pharma
1240 Sugg Parkway
Greenville, NC 27834
06/2015

Lot: / Exp:

4379L01 Rev. 9

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

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Vitamin B6 (as Pyridoxine
Hydrochloride) 25 mg
Folic Acid 2.2 mg†
Vitamin B12 (as Cyanocobalamin)
1.0 mg

Dietary Supplement
Formulated to provide a good source of Folate as a dietary supplement.*

100 Tablets

mayne pharma

FABB 
folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:68308-326
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	2.2 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
TRIACETIN (UNII: XHX3C3X673)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
OLEIC ACID (UNII: 2UMI9U37CP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:68308-326-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/01/2009	03/31/2019

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	10 mm
imprint

Labeler - Mayne Pharma Inc. (867220261)

Revised: 7/2017

Document Id: 1e4a0fbd-2eb6-4398-8037-e6b8620344be

58476-3

Set id: baf8cfad-1ff4-4baf-9179-3dad9d36fbb0

Version: 4

Effective Time: 20170728