Prenaissance

Generic Name: ascorbic acid, tricalcium phosphate, ferrous fumarate, cholecalciferol, d-alpha tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium
Dosage Form: capsule

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.

Prenaissance Capsules

Rx Only

DESCRIPTION:

Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.

EACH SOFTGEL CONTAINS:

Vitamin C (ascorbic acid, USP) 28 mg
Calcium (tricalcium phosphate, NF) 160 mg
Iron (ferrous fumarate, USP) 29 mg
Vitamin D3 (cholecalciferol, USP) 800 IU
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine HCl, USP) 25 mg
Folic Acid, USP 1.25 mg
DHA (docosahexaenoic acid) 325 mg
Docusate Sodium, USP 55 mg

OTHER INGREDIENTS:

gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red #40, ethyl vanillin, FD&C yellow #5, FD&C blue #1.

INDICATIONS:

Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a physician.

WARNING:

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.

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.

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:

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.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

Prenaissance Capsules are supplied in child-resistant bottles of 30 softgels (NDC# 42192-341-30).

Store at 20° - 25°C (68° - 77°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
1-800-541-4802

Rev. 0411

PRINCIPAL DISPLAY PANEL - 30 Softgels

NDC 42192-341-30

Prenaissance Capsules

Rx Prenatal Vitamin and DHA

Rx only              30 Softgels

Acella
PHARMACEUTICALS, LLC

Prenaissance 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-341
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 28 mg
TRICALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 160 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1.25 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 325 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 55 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
SOYBEAN OIL  
YELLOW WAX  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
ETHYL VANILLIN  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 341
Contains         
Packaging
# Item Code Package Description
1 NDC:42192-341-30 30 CAPSULE, LIQUID FILLED in 1 CAPSULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/19/2011
Labeler - Acella Pharmaceuticals, LLC (825380939)
Registrant - Acella Pharmaceuticals, LLC (825380939)
Establishment
Name Address ID/FEI Operations
Viva 253288898 MANUFACTURE(42192-341)
Revised: 08/2012
 
Acella Pharmaceuticals, LLC



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