PRENATAL PLUS

Manufacturer
Apace Packaging, LLC | Nexgen Pharma, Inc.
Effective date
2018-05-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:57:28

Label at a glance#

ProductPRENATAL PLUS
Active ingredientVITAMIN A ACETATE, CYANOCOBALAMIN, ASCORBIC ACID, CHOLECALCIFEROL, FOLIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, .BETA.-CAROTENE, ZINC OXIDE, CALCIUM CARBONATE, FERROUS FUMARATE, PYRIDOXINE HYDROCHLORIDE, CUPRIC OXIDE
Label structure8 sections

Boxed warning

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.

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

BOXED WARNING SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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 SECTION

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

HOW SUPPLIED SECTION

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

PACKAGE LABEL.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)

1
1
2
2
3
3

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)

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-668-10EA - Each65162-6684a4ff724-e95b-437f-8203-5bda0238752d12012-07-24
65162-668-50EA - Each65162-6683d38ed15-6585-49a5-a931-5f89421854a312012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15338-52215338-522-10
65162-668

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0a48d14a-1d81-f2ca-e063-6394a90ac98e6ce0c6be-4ba3-2dfd-e053-2a91aa0af5972023-11-16Boxed warning, WarningsExact identifier
spl set id: 6ce0c6be-4ba3-2dfd-e053-2a91aa0af597

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.