FOLA-B COMPLEX- pyridoxine hydrochloride, folic acid, cyanocobalamin tablet

Fola-B Complex by

Drug Labeling and Warnings

Fola-B Complex by is a Other medication manufactured, distributed, or labeled by Trifluent Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM

FOLA-B COMPLEX - Rx only [Dispensed by Prescription]
Prescription only Folic Acid Containing Dietary Supplement

STATEMENT OF IDENTITY

FOLA-B COMPLEX
ACTIVE INGREDIENTS: Each tablet contains pyridoxine hydrochloride, folic acid, cyanocobalamin.

Serving Size: 1 Tablet  Serving per Container: 30
Each Tablet Contains:		% Daily Value
Vitamin B-6 (as Pyridoxine HCl)	10 mg	588%
Folate	1,667 mcg DFE (from 1,000 mcg Folic Acid)	417%
Vitamin B-12  (as Cyanocobalamin)	400 mcg	16,667%

OTHER INGREDIENTS: Calcium Phosphate, Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Silicon Dioxide, Triacetin, Polydextrose, Wax.

DESCRIPTION

FOLA-B COMPLEX is an orally administered prescription only dietary supplement. 

INDICATIONS

FOLA-B COMPLEXTM tablets are indicated for nutritional support and folic acid supplementation.*

CONTRADINDICATIONS

FOLA-B COMPLEX is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Keep this and all medications out of the reach of children. 

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

ADVERSE REACTIONS

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

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact: Trifluent Pharma, LLC at 1-210-944-6920.

DOSAGE AND ADMINISTRATION

One tablet daily with food or as directed by a physician. 

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

PRECAUTION:

Folic acid in doses as low as 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.

STORAGE

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Avoid excessive heat, light and moisture.

How Supplied

Fola-B Complex, 30 Tablets in a bottle, 73352-890-30^

Tablet is pink, round. ​

Distributed by:
Trifluent Pharma, LLC,
San Antonio TX

Rev 01 890-30

TAMPER EVIDENT Double safety sealed for your protection. Do not use if either
seal is broken or missing.

MADE IN USA

*This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease.

^Trifluent Pharma does not represent this product code to be National Drug Code (NDC). Product
codes are formatted according to standard industry practice to meet the formatting requirement by
pedigree reporting and supply-chain control including pharmacies.

This product is a prescription-folate with or without other dietary ingredients that – due
to increased folate levels increased risk associated with masking B12 deficiency
(pernicious anemia) requires administration under the care of a licensed
medical practitioner. The most appropriate way to ensure pedigree reporting
consistent with these regulatory guidelines and safety monitoring is to dispense this
product only by prescription. This is not an Orange Book product. This product may be
administered only under a physician's supervision and all prescriptions using this
product shall be pursuant to state statues as applicable. The ingredients, indication,
or claims of this product are not to be construed to be drug claims.
1. Federal Register Notice of
August 2, 1973 (38 FR 20750)
2. Federal Register Notice of
October 17, 1980 (45 FR
69043, 69044)
3. Federal Register Notice of
April 9, 1971 (36 FR 6843)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOLA-B COMPLEX 
pyridoxine hydrochloride, folic acid, cyanocobalamin tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:73352-890
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	400 ug

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACETIN (UNII: XHX3C3X673)
POLYDEXTROSE (UNII: VH2XOU12IE)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:73352-890-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		07/18/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
scoring	1
size (solid drugs)	19 mm

Labeler - Trifluent Pharma LLC (117167281)