Indications and uses
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.
PRENATAL PLUS
- Manufacturer
- AvPAK
- Effective date
- 2022-04-12
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 20:40:58
Label at a glance#
ProductPRENATAL PLUS
Active ingredient.ALPHA.-TOCOPHEROL ACETATE, DL-, VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
Label structure7 sections
Dosage and administration
Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner.
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner.
INDICATIONS AND USAGE
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.
WARNINGS
| 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
High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.
Call your licensed medical practitioner about side effects.
To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com
DOSAGE AND ADMINISTRATION
Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner.
HOW SUPPLIED
Prenatal Plus Vitamin and Mineral Tablets are beige colored tablets, debossed with "677" on one side, dispensed in bottles of 100 tablets (NDC 50268-677-01)
Storage
STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF).
Protect from light and moisture. Dispense in a tight, light-resistant container with child-resistant closure.
Manufactured for:
AvKARE
Pulaski, TN 38478
Rev. 11/2021
AV Rev. 11/2021
PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| VITAMIN A Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50268-677-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6512-111a-e063-dadaa90a10e2 | Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Prenatal / Postnatal Dietary Supplement Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50268-677-01 | PRENATAL PLUS | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50268-677 | 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 [AVPAK] | 2 | Legacy NDC, 1 package rows | 20220413_da57de90-d103-71d2-e053-2a95a90afecc.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50268-677-01 | EA - Each | 50268-677 | a744c482-bfca-421d-9cc4-e9951c6bc7ad | 1 | 2022-04-06 |
Products#
Every source-derived product name is available through these pages.
- 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
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .ALPHA.-TOCOPHEROL, DL-
- ASCORBYL PALMITATE
- BUTYLATED HYDROXYTOLUENE
- CROSCARMELLOSE SODIUM
- CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 5
- FD&C YELLOW NO. 6
- GELATIN
- HYPROMELLOSES
- MAGNESIUM STEARATE
- MALTODEXTRIN
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- SILICON DIOXIDE
- SODIUM ASCORBATE
- SODIUM BENZOATE
- SORBIC ACID
- STARCH, CORN
- STEARIC ACID
- SUCROSE
- SUNFLOWER OIL
- TITANIUM DIOXIDE
- TRIACETIN
- VITAMIN A ACETATE
- VITAMIN A
- BETA CAROTENE
- ASCORBIC ACID
- CHOLECALCIFEROL
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50268-677 | 50268-677-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0e76f0d9-0ac2-e097-e063-6394a90adba2 | da57de90-d103-71d2-e053-2a95a90afecc | 2024-01-08 | Warnings | da57de90-d103-71d2-e053-2a95a90afecc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.