Medication Guide App

PreNata Chewable Tablets

Generic Name: folic acid, iron, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine and cyanocobalamin
Dosage Form: tablet, chewable

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.

PréNata™ Chewable Tablets

PréNata™ Chewable Tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both the lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.

Each fruit-flavored Chewable tablet contains:

VITAMINS:
C (as sodium ascorbate and ascorbic acid) 120 mg
D3 (as cholecalciferol) 400 IU
E (as dl-alpha tocopheryl acetate) 11 IU
B1 (as thiamin mononitrate) 2 mg
B2 (as riboflavin) 3 mg
B3 (as niacinamide) 20 mg
B6 (as pyridoxine HCL) 10 mg
Folic Acid 1 mg
B12 (as cyanocobalamin) 12 mcg
MINERAL:
Iron (as ferrous fumarate) 29 mg

OTHER INGREDIENTS

Microcrystaline cellulose, xylitol, magnesium stearate, talc, natural fruit flavor, malic acid, sucralose, citric acid, and mixed tocopherols.

DIRECTIONS

One tablet daily with a meal, or as directed by a physician. Tablets should be chewed or crushed before swallowing.

CAUTION

Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Adverse Reactions

In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

How is PreNata Chewable Tablets Supplied

PréNata™ Chewable Tablets are light brown to brown-speckled, fruit-flavored, round tablets debossed "SCI" on one side.

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).

PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure.

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Sancilio & Company, Inc.,
Riviera Beach, FL 33404
(800) SCI-8711

© 2011 Sancilio & Company, Inc.

REV: 12/06/11

PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label

44946-1041-5
Rx only

PréNata

FOLIC ACID + IRON
MULTIVITAMIN

Chewable
Tablets

Provides vitamin and
mineral supplementation
throughout pregnancy
and postnatal

Sugar & Gluten Free

Sancillio & Company, Inc
Developing good science into great medicine

90
TABLETS

PRENATA 
folic acid, iron, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1041
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
IRON (IRON) IRON 29 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 11 [iU]
THIAMINE (THIAMINE) THIAMINE 2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACIN (NIACIN) NIACIN 20 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Xylitol  
Magnesium Stearate  
Talc  
Malic Acid  
Sucralose  
Anhydrous Citric Acid  
Tocopherol  
Product Characteristics
Color BROWN (light brown to brown-speckled) Score no score
Shape ROUND Size 16mm
Flavor FRUIT Imprint Code SCI
Contains         
Packaging
# Item Code Package Description
1 NDC:44946-1041-5 12 BOTTLE (BOTTLE) in 1 CASE
1 90 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/31/2011
Labeler - Sancilio & Company Inc (176681257)
Revised: 12/2011
 
Sancilio & Company Inc
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