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  5. Label Information: Prenaissance Plus

FDA Label for Prenaissance Plus

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION:
    3. OTHER INGREDIENTS:
    4. INDICATIONS:
    5. CONTRAINDICATIONS:
    6. WARNING:
    7. BOXED WARNING
    8. PRECAUTIONS:
    9. ADVERSE REACTIONS:
    10. CAUTION:
    11. DOSAGE AND ADMINISTRATION:
    12. NOTICE:
    13. HOW SUPPLIED:
    14. PRINCIPAL DISPLAY PANEL - 30 SOFTGELS

Prenaissance Plus Product Label

The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx Only

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 Acid1 mg
Docusate Sodium50 mg
DHA (Docosahexaenoic acid)250 mg

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


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.


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:



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.


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.


Boxed Warning



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.


Notice:



Contact the moisture can discolor or erode the capsule.


How 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.


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 - 1459ccd1 2372 450f ac17 382ca9a5b175 01

PRINCIPAL DISPLAY PANEL - 30 Softgels - 1459ccd1 2372 450f ac17 382ca9a5b175 01


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