Foltabs 800 Tablets

Drug Labeling and Warnings

Drug Details [pdf]

FOLTABS 800- vitamins tablets tablet 
Mayne Pharma Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Foltabs 800 Tablets

DESCRIPTION

Foltabs™ 800 is a scored green round multivitamin tablet. The tablet is debossed with "ML" on the scored side

and plain on the other.

Each tablet contains:

Vitamin B6 (Pyridoxine HCl) ................................................................. 10 mg

Folic Acid ...............................................................................................800 μg

Cyanocobalamin .....................................................................................115 μg

INACTIVE INGREDIENTS: Dicalcium Phosphate Dihydrate, Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Polydextrose, Hypromellose, Polyethylene Glycol, Titanium Dioxide, D&C Yellow #10, Triacetin, FD&C Blue #1, FD&C Yellow #6

INDICATIONS AND USAGE

Foltabs™ 800 is a multivitamin prescription supplement indicated for the use in improving the nutritional status of patients as prescribed by their physician.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other

megaloblastic anemias where vitamin B12 is deficient.

KEEP OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

General

NOTICE: Contact with moisture can produce surface discoloration or erosion of

the tablet.

Folic acid in doses above 0.1 mg may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

FOLCAPS Tablet is a round, green-coated bisected tablet debossed 'ML' on one side and plain on the other side.

Bottles of 60 tablets ................................. NDC: 68308-325-60

DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE

USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room

temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C

(59°-86°F). [See current USP].

Manufactured for:

Midlothian Laboratories

Montgomery, AL 36117

www.midlothianlabs.com

Rev. 12/09

CONTAINER LABEL

Immediate Container Label

FOLTABS 800 
vitamins tablets tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68308-325
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)	160 mg

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	ML
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68308-325-10	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2009	06/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/2009	06/30/2019

Labeler - Mayne Pharma Inc (867220261)

Revised: 7/2017

Document Id: e572ad8e-5e6d-4b5a-8934-77b0497e3495

34391-3

Set id: a0c87255-6105-4ae6-a698-dae0115265ab

Version: 2

Effective Time: 20170727