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

Foltabs 800 Container Label

Immediate Container Label

FOLTABS 800 
vitamins tablets tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68308-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE115 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID800 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN115 ug
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 160 mg
Product Characteristics
ColorGREENScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code ML
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68308-325-1060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200906/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/200906/30/2019
Labeler - Mayne Pharma Inc (867220261)

Revised: 7/2017
 

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