Fabb (Folic Acid, Cyanocobalamin, And Pyridoxine Hydrochloride) Tablet [H2-Pharma, Llc] -

FABB (FOLIC ACID, CYANOCOBALAMIN, AND PYRIDOXINE HYDROCHLORIDE) TABLET [H2-PHARMA, LLC]
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NDC	61269-326-10
Set ID	9df0db63-fe4f-43ad-9830-d53009a96004
Category	DIETARY SUPPLEMENT
Packager	H2-Pharma, LLC
Generic Name
Product Class
Product Number
Application Number

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DOSAGE AND ADMINISTRATION

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

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.

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.
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SAFE HANDLING WARNING

KEEP OUT OF THE REACH OF CHILDREN .
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Tamper Evidence feature

Do not use if seal under cap is torn, broken or missing.
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HEALTH CLAIM

*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.
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STORAGE CONDITIONS

Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from light and moisture.
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HEALTH CLAIM

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

4379L01 Rev. 10

61269-326-10
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PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

FaBB

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

Dietary Supplement

100 Tablets

H2 pharma

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INGREDIENTS AND APPEARANCE

FABB
folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:61269-326
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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 HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:61269-326-10	100 in 1 BOTTLE

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

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

Labeler - H2-Pharma, LLC (028473634)

Name	Address	ID/FEI	Business Operations
Establishment
Ion Labs		106499791	MANUFACTURE

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Medic

FABB (FOLIC ACID, CYANOCOBALAMIN, AND PYRIDOXINE HYDROCHLORIDE) TABLET [H2-PHARMA, LLC]

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