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DailyMed Label: Prenaissance Plus

Title
DailyMed Label: Prenaissance Plus
Date
2024
Document type
DailyMed Prescription
Name
Prenaissance Plus
Generic name
CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT
Manufacturer
Acella Pharmaceuticals, LLC
Product information
NDC: 42192-343
Product information
NDC: 42192-343
Product information
NDC: 42192-343
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 Sodium 50 mg    DHA (Docosahexaenoic acid)  250 mg 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.
Dosage
Usual adult dose is 1 (one) softgel daily or as directed by a physician.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.
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.
Package label
NDC 42192-343-30 Prenaissance Plus R x Prenatal Vitamin and DHA R x only              30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 30 Softgels

1 organization

1 product

Product
Prenaissance Plus
Organization
Acella Pharmaceuticals, LLC