Boxed warning
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
PreNatal Vitamins Plus
Rx Only
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| Each Tablet Contains: | Amount per Tablet | % Daily Value |
| Vitamin A (Acetate and Beta Carotene) | 4000 I.U. | 80% |
| Vitamin C (Ascorbic Acid) | 120mg. | 200% |
| Vitamin D-3 (Cholecalciferol) | 400 I.U. | 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 (Niacinamide) | 20 mg | 100% |
| Vitamin B-6 (Pyridoxine HCl) | 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) | 25 mg. | 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, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.
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.
Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.
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.
Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.
Manufactured for: Boca Pharmacal, Inc., Coral Springs, FL 33065
www.bocapharmacal.com 1-800-354-8460 Iss. 06/12
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM 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 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
| cf050ccd-1144-f76a-e00d-e5698d8597d4 | Product name | 6 | 20250625 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-3545-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-40dd-60a7-e053-dbdaa90a05bd | Unknown Title |
| 63629-3545-2 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-40dd-60a7-e053-dbdaa90a05bd | Unknown Title |
| 63629-3545-3 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-40dd-60a7-e053-dbdaa90a05bd | Unknown Title |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-3545-1 | PreNatal Vitamins Plus | 100 in 1 BOTTLE | TABLET | 100 | 1000 | |
| 63629-3545-2 | PreNatal Vitamins Plus | 30 in 1 BOTTLE | TABLET | 30 | 1000 | |
| 63629-3545-3 | PreNatal Vitamins Plus | 90 in 1 BOTTLE | TABLET | 90 | 1000 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-3545 | PRENATAL VITAMINS PLUS TABLET [BRYANT RANCH PREPACK] | 1000 | Legacy NDC, 3 package rows | 20140723_f74db588-313c-4eec-8c9d-9ff9455c9fa6.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64376-816-01 | EA - Each | 64376-816 | b1da424c-58a4-4b96-a907-e57031a998e8 | 1 | 2012-07-24 |
| 64376-816-05 | EA - Each | 64376-816 | d0f5dca3-d338-4e25-964c-e75461bf70f9 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE | ACTIVE INGREDIENT | 9E8X80D2L0 | 1000 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1000 | |
| CALCIUM | ACTIVE INGREDIENT | SY7Q814VUP | 1000 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1000 | |
| COPPER | ACTIVE INGREDIENT | 789U1901C5 | 1000 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1000 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1000 | |
| IRON | ACTIVE INGREDIENT | E1UOL152H7 | 1000 | |
| NIACIN | ACTIVE INGREDIENT | 2679MF687A | 1000 | |
| PYRIDOXINE | ACTIVE INGREDIENT | KV2JZ1BI6Z | 1000 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1000 | |
| THIAMINE | ACTIVE INGREDIENT | X66NSO3N35 | 1000 | |
| VITAMIN A | ACTIVE INGREDIENT | 81G40H8B0T | 1000 | |
| ZINC | ACTIVE INGREDIENT | J41CSQ7QDS | 1000 | |
| .ALPHA.-TOCOPHEROL | ACTIVE MOIETY | H4N855PNZ1 | 1000 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1000 | |
| CALCIUM | ACTIVE MOIETY | SY7Q814VUP | 1000 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1000 | |
| COPPER | ACTIVE MOIETY | 789U1901C5 | 1000 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1000 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1000 | |
| IRON | ACTIVE MOIETY | E1UOL152H7 | 1000 | |
| NIACIN | ACTIVE MOIETY | 2679MF687A | 1000 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1000 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1000 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1000 | |
| VITAMIN A | ACTIVE MOIETY | 81G40H8B0T | 1000 | |
| ZINC | ACTIVE MOIETY | J41CSQ7QDS | 1000 | |
| .ALPHA.-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | 1000 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 1000 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1000 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1000 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 1000 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 1000 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1000 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1000 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1000 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1000 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1000 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1000 | |
| METHYLCELLULOSE (15 CPS) | INACTIVE INGREDIENT | NPU9M2E6L8 | 1000 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1000 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1000 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 1000 | |
| SOY PROTEIN | INACTIVE INGREDIENT | R44IWB3RN5 | 1000 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1000 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1000 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1000 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1000 | |
| TRICALCIUM PHOSPHATE | INACTIVE INGREDIENT | K4C08XP666 | 1000 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63629-3545 | 63629-3545-1, 63629-3545-2, 63629-3545-3 |
| 64376-816 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EFFERVESCENT / ORAL | 14404 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SUPPOSITORY / RECTAL | 16 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, FILM COATED / ORAL | 2 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CREAM / TOPICAL | NA | ||
| .ALPHA.-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | TABLET / ORAL | 0.12 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | CAPSULE / ORAL | 200 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 52.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| .ALPHA.-TOCOPHEROL, DL- | .ALPHA.-TOCOPHEROL, DL- | 7QWA1RIO01 | OINTMENT / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| ACACIA | ACACIA | 5C5403N26O | SYRUP / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER / VAGINAL | 430 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| ACACIA | ACACIA | 5C5403N26O | SUSPENSION / ORAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| ACACIA | ACACIA | 5C5403N26O | SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg |
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 |
|---|---|---|---|---|---|---|
| f22389d3-ea5a-46bb-8a26-852a7080e56f | f74db588-313c-4eec-8c9d-9ff9455c9fa6 | 2014-07-17 | Boxed warning, Warnings | f22389d3-ea5a-46bb-8a26-852a7080e56f f74db588-313c-4eec-8c9d-9ff9455c9fa6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.