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FaBB Tablets Prescribing Information

Package insert / product label
Generic name: pyridoxine hydrochloride, folic acid and cyanocobalamin
Dosage form: tablet
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 24, 2023.

FaBB Tablets Description

Foltabs™ Prenatal is a scored white oval multivitamin/

multimineral tablet. The tablet is debossed with “ML 160” on the scored side

and plain on the other.

Each tablet contains:

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

Folic Acid ..... 2.2 mg

Cyanocobalamin .....1 mg

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

Indications and Usage for FaBB Tablets

Foltabs™ Prenatal 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/Side Effects

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

FaBB Tablets Dosage and Administration

One tablet daily or as directed by a physician.

How is FaBB Tablets supplied

FOLCAPS Tablet is a round, pink-coated tablet debossed 'ML' on one side and '326' on the other side.

Bottles of 100 tablets ..... NDC 68308-326-10

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

FaBB Container Label

Immediate Container Label

FABB TABLETS
vitamins tablets tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68308-326
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) CYANOCOBALAMIN1 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 238 mg
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeML;326
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68308-326-10100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2009
Labeler - Midlothian Laboratories (142122824)

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