Boxed warning
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.
PreNatal 19
- Manufacturer
- Nationwide Laboratories, LLC
- Effective date
- 2020-03-03
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:39:54
Label at a glance#
ProductPreNatal 19
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, DOCUSATE SODIUM
Label structure13 sections
Dosage and administration
One tablet daily, or as directed by a physician.
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION
PreNatal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.
| Each tablet contains: | |
| Vitamin A (as beta carotene) | 1000 IU |
| Vitamin C (ascorbic acid) | 100 mg |
| Vitamin D (as cholecalciferol) | 400 IU |
| Vitamin E (as dl-alpha-tocopheryl acetate) | 30 IU |
| Thiamine Mononitrate (Vitamin B1) | 3 mg |
| Riboflavin (Vitamin B2) | 3 mg |
| Niacin (as niacinamide) | 15 mg |
| Vitamin B6 (as pyridoxine HCl) | 20 mg |
| Folate (folic acid) | 1 mg |
| Vitamin B12 (as cyanocobalamin) | 12 mcg |
| Pantothenic Acid | |
| (as calcium pantothenate) | 7 mg |
| Calcium (as calcium carbonate) | 200 mg |
| Iron (as ferrous fumarate) | 29 mg |
| Zinc (as zinc oxide) | 20 mg |
| Docusate Sodium | 25 mg |
INACTIVE INGREDIENT SECTION
OTHER INGREDIENTS
Carnauba Wax, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Talc, and Titanium Dioxide.
INDICATIONS
PreNatal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreNatal 19 tablets are also useful in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
WARNING
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.
PRECAUTIONS
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
DOSAGE AND ADMINISTRATION
One tablet daily, or as directed by a physician.
HOW SUPPLIED
PreNatal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "C41," packaged in bottles of 100 tablets.
NDC 42937-706-10.
STORAGE
Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.
PHARMACIST
Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.
SPL UNCLASSIFIED SECTION
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.
SPL UNCLASSIFIED SECTION
Reserved for Professional Recommendation.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
SPL UNCLASSIFIED SECTION
Distributed by:
Nationwide Laboratories LLC
Iselin NJ 08830
Lot No.: Exp. Date: Rev. 12/12
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
Nationwide Laboratories LLC
NDC 42937-706-10
PreNatal 19
Tablets
Vitamins and Minerals
with Folic Acid
Rx only
100 Tablets
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42937-706-10 | 2020-03-03 | C162847 | 48780-1 | 9855e2a2-4515-60a7-e053-dbdaa90a05bd | PreNatal 19 |
| 42937-706-10 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4515-60a7-e053-dbdaa90a05bd | PreNatal 19 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| .BETA.-CAROTENE | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| CALCIUM CARBONATE | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| CALCIUM PANTOTHENATE | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| FERROUS FUMARATE | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| .BETA.-CAROTENE | ACTIVE MOIETY | 01YAE03M7J | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| acacia | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- PreNatal 19
- .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and DOCUSATE SODIUM
- BETA CAROTENE
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .ALPHA.-TOCOPHEROL, DL-
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- CALCIUM PANTOTHENATE
- PANTOTHENIC ACID
- CALCIUM CATION
- CALCIUM CARBONATE
- FERROUS FUMARATE
- FERROUS CATION
- ZINC OXIDE
- ZINC CATION
- DOCUSATE SODIUM
- DOCUSATE
- Carnauba Wax
- Silicon Dioxide
- Acacia
- Hypromellose, Unspecified
- Magnesium Stearate
- Microcrystalline Cellulose
- Polyethylene Glycol, Unspecified
- Stearic Acid
- Talc
- Titanium Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42937-706 | 42937-706-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Talc | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET, CHEWABLE / ORAL | 121 mg | ||
| acacia | ACACIA | 5C5403N26O | POWDER, FOR SOLUTION / ORAL | NA | ||
| acacia | ACACIA | 5C5403N26O | GUM, CHEWING / BUCCAL | 280 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| Talc | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| Talc | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg |
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 |
|---|---|---|---|---|---|---|
| c3ba0add-01e8-4e3b-8424-e60c6acdc4c0 | aab1f6c4-4fdb-49df-9610-31c5d1e9a5a5 | 2021-12-20 | Boxed warning, Warnings | aab1f6c4-4fdb-49df-9610-31c5d1e9a5a5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.