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Prenaissance Plus Prescribing Information

Package insert / product label
Generic name: prenatal vitamin
Dosage form: capsules
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 18, 2024.

Rx Only

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

Prenaissance Plus Description

Prenaissance Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with "343" on one side.

EACH SOFTGEL CONTAINS:

Calcium (Calcium citrate) 100 mg
Iron (Carbonyl Iron) 28 mg
Vitamin D3 (Cholecalciferol)400 IU
Vitamin E (dl-alpha tocopherol acetate 30 IU
Vitamin B6 (Pyridoxine HCI) 25 mg
Folic Acid 1 mg
Docusate Sodium50 mg
DHA (Docosahexaenoic acid) 250 mg

OTHER INGREDIENTS:

soybean oil, yellow bee's wax, lecithin, natural orange cream flavoring, gelatin, glycerine, purified water, carmine, titanium dioxide, ethyl vanillin, FD&C#40, and FD&C Blue #1.

Indications and Usage for Prenaissance Plus

Prenaissance Plus is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily 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.

CAUTION:

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) daily.

Prenaissance Plus Dosage and Administration

Usual adult dose is 1 (one) softgel daily or as directed by a physician.

NOTICE:

Contact the moisture can discolor or erode the capsule.

How is Prenaissance Plus supplied

Prenaissance Plus is supplied in child-resistant bottles of 30 softgels (NDC# 42192-343-30).

Store at 15° - 30°C (59° - 86°F) [See USP].

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

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009

PRINCIPAL DISPLAY PANEL - 30 Softgels

NDC 42192-343-30

Prenaissance Plus

Rx Prenatal Vitamin and DHA

Rx only 30 Softgels

Acella
PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - 30 Softgels
PRENAISSANCE PLUS
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent capsule, liquid filled
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-343
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS 100 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
Inactive Ingredients
Ingredient NameStrength
SOYBEAN OIL (UNII: 241ATL177A)
YELLOW WAX (UNII: 2ZA36H0S2V)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETHYL VANILLIN (UNII: YC9ST449YJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize25mm
FlavorImprint Code343
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42192-343-3030 in 1 CAPSULE; Type 0: Not a Combination Product10/07/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/07/2011
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Acella Pharmaceuticals, LLC (825380939)
Establishment
NameAddressID/FEIBusiness Operations
Acella Pharmaceuticals, LLC825380939manufacture(42192-343)

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