Boxed warning
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
PRENATAL VITAMINS PLUS LOW IRON TABLETS
- Manufacturer
- Carilion Materials Management
- Effective date
- 2017-12-26
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 20:25:09
Label at a glance#
ProductPrenatal Vitamins Plus Low Iron
Active ingredientVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, ZINC, COPPER
Label structure10 sections
Storage and handling
Store at room temperature, USP. Dispense in a well closed light resistant container.
Label contents#
Full prescribing information#
BOXED WARNING SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DESCRIPTION SECTION
| Each Tablet Contains: | Amount Per Tablet | % Daily Value |
|---|---|---|
| Vitamin A (from Acetate and Beta Carotene) | 4000 IU | 80% |
| Vitamin C (Ascorbic Acid) | 120 mg | 200% |
| Vitamin D-3 (Cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-Alpha Tocopheryl Acetate) | 22 mg | 73% |
| Vitamin B-1(Thiamine Mononitrate) | 1.84 mg | 123% |
| Vitamin B-2 (Riboflavin) | 3 mg | 176% |
| Niacin (as Niacinamide) | 20 mg | 100% |
| Vitamin B-6 (Pyridoxine HCI) | 10 mg | 500% |
| Folic Acid | 1 mg | 200% |
| Vitamin B-12 (Cyanocobalamin) | 12 mcg | 200% |
| Calcium (from Calcium Carbonate) | 200 mg | 20% |
| Iron (Ferrous Fumarate) | 27 mg | 150% |
| Zinc (Zinc Oxide) | 25mg | 167% |
| Copper (Cupric Oxide) | 2 mg | 100% |
Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.
INDICATIONS & USAGE SECTION
Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.
DOSAGE & ADMINISTRATION SECTION
Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.
CONTRAINDICATIONS SECTION
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PRECAUTIONS SECTION
Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.
BOXED WARNING SECTION
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.
STORAGE AND HANDLING SECTION
Store at room temperature, USP. Dispense in a well closed light resistant container.
HOW SUPPLIED
Product: 68151-5878
NDC: 68151-5878-1 1 TABLET in a BLISTER PACK
PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET
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 |
| COPPER Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NIACIN 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 |
|---|---|---|---|---|---|
| 68151-5878-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-437e-f424-e053-dadaa90a57ce | PRENATAL VITAMINS PLUS LOW IRON TABLETS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-5878-1 | Prenatal Vitamins Plus Low Iron | 1 in 1 BLISTER PACK | TABLET | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-5878 | PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20171227_5c1eb2c1-1046-4a4a-939b-5c1043c6ccdd.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 39328-106-10 | EA - Each | 39328-106 | f7a4b752-043d-4e8c-9e22-562606df7498 | 1 | 2013-07-02 |
| 39328-106-50 | EA - Each | 39328-106 | ad2ea590-9335-491b-af0b-28c3b864f779 | 1 | 2014-04-03 |
Products#
Every source-derived product name is available through these pages.
- Prenatal Vitamins Plus Low Iron
- Prenatal with Ferrous Fum and Folic Acid
- VITAMIN A ACETATE
- VITAMIN A
- .BETA.-CAROTENE
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .ALPHA.-TOCOPHEROL, DL-
- THIAMINE
- THIAMINE ION
- RIBOFLAVIN
- NIACIN
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- CALCIUM CARBONATE
- CALCIUM CATION
- IRON
- ZINC
- COPPER
- ASCORBYL PALMITATE
- ANHYDROUS CITRIC ACID
- ETHYLCELLULOSE, UNSPECIFIED
- FD&C BLUE NO. 2
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- DEXTROSE, UNSPECIFIED FORM
- ACACIA
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- STARCH, CORN
- MALTODEXTRIN
- METHYLCELLULOSE (100 MPA.S)
- MICROCRYSTALLINE CELLULOSE
- MINERAL OIL
- GLYCERYL MONOSTEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68151-5878 | 68151-5878-1 |
| 39328-106 |
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 |
|---|---|---|---|---|---|---|
| Prenatal Plus Vitamins | PRENATAL WITH FERROUS FUMARATE AND FOLIC ACID | Patrin Pharma, Inc. | 59c5c1a4-3f42-441a-b842-903f9bab346f | 2022-01-13 | Boxed warning | 39328-106 |
| 84181497-355d-43d7-8d42-a30d69b97eaa | 5c1eb2c1-1046-4a4a-939b-5c1043c6ccdd | 2017-12-26 | Boxed warning | 84181497-355d-43d7-8d42-a30d69b97eaa 5c1eb2c1-1046-4a4a-939b-5c1043c6ccdd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.