FOLCAPS- 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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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

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.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW 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

Folcaps Container Label

Immediate Container Label

FOLCAPS 
vitamins tablets tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68308-324
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2.2 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN500 ug
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 256.4 mg
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize10mm
FlavorImprint Code ML;324
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68308-324-10100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/200912/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/200912/31/2016
Labeler - Mayne Pharma Inc. (867220261)

Revised: 12/2017
 
Mayne Pharma Inc.