PRENATVITE PLUS TABLETS Rx Prenatal Vitamin Tablet with Prescription Folic Acid
- Manufacturer
- SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
- Effective date
- 2020-02-05
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:41:23
Label at a glance#
ProductPRENATVITE PLUS
Active ingredientVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, FERROUS FUMARATE, INOSITOL, CITRUS BIOFLAVONOIDS, CALCIUM, BORON, ZINC OXIDE, CUPRIC OXIDE
Label structure4 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
SUPPLEMENT FACTS:
Serving Size: One Tablet
PRENATVITE PLUS is an orally administered prenatal/postnatal prescription folic acid-containing dietary Supplement and should be administered under the supervision of a licensed medical practitioner.
Each PRENATVITE PLUS tablet contains: | ||
VITAMIN A (AS ACETATE, BETA CAROTENE) | 1200 MCG | |
VITAMIN C (ASCORBIC ACID) | 120 MG | |
VITAMIN D3 (AS CHOLECALCIFEROL) | 10 MCG | |
VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE) | 9.2 MG | |
VITAMIN B1 (AS THIAMINE MONONITRATE) | 1.84 MG | |
| VITAMIN B2 (AS RIBOFLAVIN) | 3 MG | |
VITAMIN B3 (AS NIACINAMIDE) | 20 MG | |
VITAMIN B6 (AS PYRIDOXINE HCL) | 10 MG | |
FOLIC ACID | 1000 MCG | |
VITAMIN B12 (AS CYANOCOBALAMIN) | 12 MCG | |
CALCIUM (AS CALCIUM CARBONATE) | 27 MG | |
IRON (AS FERROUS FUMARATE) | 27 MG | |
ZINC (AS ZINC OXIDE) | 25 MG | |
COPPER (AS CUPRIC OXIDE) | 2 MG | |
INOSITOL | 5 MG | |
CITRUS BIOFLAVONOIDS COMPLEX 50% | 2 MG | |
BORON (AS BORON CITRATE) | 0.2 MG | |
Other Ingredients:
microcrystalline cellulose, stearic acid, magnesium stearate, croscarmellose sodium, silicon dioxide, PEG-8000, talc, HPMC E15, HPMC E5/E6, FD&C RED #40 (LAKE), FD&C BLUE # 2 (LAKE FD&C YELLOW # 6 (LAKE).
INDICATIONS
PRENATVITE PLUS is a multi-vitamin/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.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS SECTION
WARNINGS
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. |
CAUTION: 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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.
PRECAUTIONS
Folic acid in doses above 0.1 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
DOSAGE AND ADMINISTRATION
One tablet daily or Take exactly as prescribed by your doctor.
Take PRENATVITE PLUS tablet each day at any time of day at about the same time each day.
PRENATVITE PLUS can be taken with or without food.
STORAGE
Store at 20-25°C (68-77°F) [See USP controlled room temperature].
Do not keep medicine that is out of date or that you no longer need.
Keep PRENATVITE PLUS Tablets and all medicines out of the reach of children.
NOTICE
Contact with moisture can discolor or erode the tablet.
HEALTH CLAIM SECTION
HOW SUPPLIED
Bottles of 90 tablets each - NDC 73317-1150-9
To report a serious adverse event or obtain product information, call 631-524-5758
Call your licensed medical practitioner about side effect.
You may report side effects by calling AUM 1-631-524-5758.
Manufactured and Distributed by:
AUM Pharmaceuticals
Hauppauge, NY 11788.
Made in USA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73317-1150-9 | EA - Each | 73317-1150 | 491a29a5-4d89-4701-bd4d-2885efa31c79 | 1 | 2020-07-13 |
Products#
Every source-derived product name is available through these pages.
- PRENATVITE PLUS
- VITAMIN A
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE
- .ALPHA.-TOCOPHEROL
- THIAMINE
- THIAMINE ION
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- FERROUS FUMARATE
- FERROUS CATION
- INOSITOL
- CITRUS BIOFLAVONOIDS
- HESPERIDIN
- CALCIUM
- BORON
- ZINC OXIDE
- ZINC CATION
- CUPRIC OXIDE
- CUPRIC CATION
- CROSCARMELLOSE SODIUM
- MICROCRYSTALLINE CELLULOSE
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- STEARIC ACID
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- TALC
- POLYETHYLENE GLYCOL 8000
- HYPROMELLOSES
- FD&C RED NO. 40
- FD&C BLUE NO. 2--ALUMINUM LAKE
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73317-1150 | 73317-1150-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.