PRENATAL PLUS- vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated

PRENATAL PLUS by

Drug Labeling and Warnings

PRENATAL PLUS by is a Prescription medication manufactured, distributed, or labeled by Apace Packaging, LLC, Nexgen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U.

Vitamin C (Ascorbic acid)……………………………………...........….120 mg

Vitamin D-3 (Cholecalciferol)……………….....................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mg

Thiamine (Vitamin B-1 from Thiamine Mononitrate………............…1.84 mg

Riboflavin (Vitamin B-2)………………………………………...............…3 mg

Niacin(Niacinamide)……………………………………………………....  20 mg

Vitamin B-6 (Pyridoxine HCl)…………………………………................10 mg

Folic Acid……………………………………………………............……...1 mg

Vitamin B-12 (Cyanocobalamin)……………………………................12 mcg

Calcium (Calcium Carbonate)……………………………….........…....200 mg

Iron (Ferrous Fumarate)………………………………………...........…...27 mg

Zinc (Zinc Oxide)………………………………………………...........…..25 mg

Copper (Cupric Oxide)…………………………………………...........… ..2 mg

Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc,
titanium dioxide

Indication

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception

Dosage

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

BOXED WARNING

(What is this?)

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

Precautions

Folic Acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE AND HANDLING

STORE AT CONTROLLED ROOM TEMPERATURE 15 0 - 30 0C (59 0 - 86 0F). AVOID EXCESS HEAT.

HOW SUPPLIED

Dispense in a well closed light-resistant container, with a child resistant container.

PRINCIPAL DISPLAY PANEL

Vitamin and Mineral
Tablet

Multi-Vitamin

Rx Only                      100 Tablets

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Questions or comments call 1-855-361-3993

Manufactured For:
AvKARE, Inc.
Pulaski, TN 38478


Mfg.Rev. 09/12      AV Rev. 07/17 (P)

NDC: 42291-686-01

Prenatal Plus

Vitamin and Mineral
Tablet

Multi-Vitamin

100 Tablets        Rx Only                     

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured For: AvKARE, Inc.
Pulaski, TN 38478

Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)

Mfg. Rev. 09/12
AV Rev. 07/17 (P)

INGREDIENTS AND APPEARANCE

PRENATAL PLUS 
vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 15338-522(NDC:65162-668)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	3080 [iU]
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	22 mg
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	920 [iU]
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ASCORBATE (UNII: S033EH8359)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	yellow (Tan-Yellow)	Score	no score
Shape	OVAL (Modified Oval Biconvex)	Size	19mm
Flavor		Imprint Code	G12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15338-522-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/11/2012

Labeler - Apace Packaging, LLC (361961142)

Establishment
Name	Address	ID/FEI	Business Operations
Apace Packaging, LLC		361961142	repack(15338-522) , label(15338-522)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		806784679	manufacture(15338-522)