Folcaps Tablets

Generic Name: pyridoxine hydrochloride, folic acid and cyanocobalamin
Dosage Form: tablet

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.

Folcaps Tablets

Folcaps Tablets Description

Folcaps™ is a scored red round multivitamin tablet.

Each tablet contains:

Vitamin B6 (Pyridoxine HCl) ................................................................ 25 mg

Folic Acid ................................................................................................. 2.2 mg

Cyanocobalamin ....................................................................................500 μg

INACTIVE INGREDIENTS: Dicalcium Phosphate Dihydrate, Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate

Indications and Usage for Folcaps Tablets

Folcaps™ 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.

Folcaps Tablets Dosage and Administration

One tablet daily or as directed by a physician.

How is Folcaps Tablets Supplied

FOLCAPS Tablet is a round, pink-coated tablet debossed 'ML' on one side and '324' on the other side.

Bottles of 100 tablets ................................. NDC 68308-324-10

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

FOLCAPS 
vitamins tablets tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-324
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 2.2 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 500 ug
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 256.4 mg
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor Imprint Code ML;324
Contains         
Packaging
# Item Code Package Description
1 NDC:68308-324-10 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Labeler - Midlothian Laboratories (142122824)
Revised: 11/2009
 
Midlothian Laboratories
Hide
(web2)