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NDC 42192-0341-30 Prenaissance 30; 28; 800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Prenaissance 30; 28; 800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Prenaissance is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE.

Product Information

NDC	42192-0341
Product ID	42192-341_221c7f55-aba5-4377-9d6e-499cc29e54c6
Associated GPIs	78516037000170
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Prenaissance
Proprietary Name Suffix	n/a
Non-Proprietary Name	CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	30; 28; 800; 325; 55; 29; 1.25; 25; 160
Active Ingredient Units	[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE
Labeler Name	Acella Pharmaceuticals, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], V
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42192-0341-30 (42192034130)

Pricing Information	N/A
NDC Package Code	42192-341-30
Billing NDC	42192034130
Package	30 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-341-30)
Marketing Start Date	2011-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7240d5fb-cb2d-4278-988f-c8e6bba6560d Details

SPL UNCLASSIFIED SECTION

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

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC:42192-341
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	28 mg
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	160 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	800 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.25 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	325 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	55 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SOYBEAN OIL (UNII: 241ATL177A)
YELLOW WAX (UNII: 2ZA36H0S2V)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ETHYL VANILLIN (UNII: YC9ST449YJ)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	341
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-341-30	30 in 1 CAPSULE; Type 0: Not a Combination Product	06/13/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		06/13/2011

Labeler - Acella Pharmaceuticals, LLC (825380939)

Registrant - Acella Pharmaceuticals, LLC (825380939)

Name	Address	ID/FEI	Business Operations
Establishment
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-341)

Revised: 9/2018

Document Id: 221c7f55-aba5-4377-9d6e-499cc29e54c6

Set id: 7240d5fb-cb2d-4278-988f-c8e6bba6560d

Version: 6

Effective Time: 20180912

Search by Drug Name or NDC

NDC 42192-0341-30 Prenaissance 30; 28; 800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Prenaissance 30; 28; 800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 42192-0341-30 (42192034130)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7240d5fb-cb2d-4278-988f-c8e6bba6560d Details

SPL UNCLASSIFIED SECTION

DESCRIPTION:

OTHER INGREDIENTS:

INDICATIONS:

CONTRAINDICATIONS:

WARNING:

WARNING

PRECAUTIONS:

ADVERSE REACTIONS:

CAUTION:

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 Softgels

INGREDIENTS AND APPEARANCE

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