Dosage Form: tablet, chewable
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.
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 | ||||||||||||||||||||||||||||||||||||
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| 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) |
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