PRENATABS FA - folic acid, cyanocobalamin, ascorbic acid, ferrous fumarate, .beta.-carotene, cholecalciferol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, calcium carbonate, potassium iodide, zinc oxide and .alpha.-tocopherol acetate, dl- tablet, film coated 
Cypress Pharmaceutical, 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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Prenatabs FA

Each tablet contains:



Vitamin A (beta carotene)...................4,000 IU

Vitamin C (as ascorbic acid).................120 mg

Vitamin D (D3).....................................400 IU

Vitamin E (dl-alpha tocopheryl acetate)....30 IU

Vitamin B1 (thiamine mononitrate)............3 mg

Vitamin B2 (riboflavin)..............................3 mg

Niacin (niacinamide)..............................20 mg

Vitamin B6 (pyridoxine HCl).....................3 mg

Folic Acid..............................................1 mg

Vitamin B12 (cyanocobalamin)................8 mcg

Calcium (calcium carbonate).................200 mg

Iron (ferrous fumarate)............................29 mg

Iodine (potassium iodide)......................150 mcg

Zinc (zinc oxide)....................................15 mg


Precaution

Folic Acid may obscure pernicious anemia or produce remission while neurologic progress may continue.

Suggested Dosage

One tablet daily or as directed by the physician.

Warning

Accidental overdose of iron-containing product is a leading cause of fatal poisoning in children under six.  Keep this product out of reach of children.  In case of accidental overdose, call a doctor or poison control center immediately.


Store at room temperature, USP.

Call your doctor for medical advise about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Cypress Pharmaceutical, Inc.

Madison, MS  39110

L353

Rev. 11/08



NDC 60258-190-01

Prenatabs

FA

VITAMINS AND MINERALS WITH FOLIC ACID

Rx
Only

Cypress Pharmaceutical, Inc.


100 Tablets


Prenatabs FA label

PRENATABS FA 
beta carotene, cholecalciferol, dl-alpha tocopheryl acetate, ascorbic acid, folic acid, thiamin mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, potassium iodide, zinc oxide, and ferrous fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:60258-190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN8 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION29 mg
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE4000 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE3 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION200 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION150 ug
ZINC OXIDE (ZINC CATION) ZINC CATION15 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL-30 [iU]
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (CYP;190) Size19mm
FlavorImprint Code CYP;190
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60258-190-01100 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other07/23/199901/01/2011
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Cypress Pharmaceutical, Inc. (790248942)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122manufacture(60258-190)

Revised: 2/2015
 
Cypress Pharmaceutical, Inc.