Before, during and after pregnancy, One tablet and One enteric-coated softgel capsule taken by mouth daily, or as prescribed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
www.trigenlab.comVena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, and omega-3 fatty acids, supplied as tablets and enteric coated softgel capsules. The Vena-Bal DHA tablet is a yellow, oval tablet debossed "TL601". The enteric-coated DHA softgel capsule is a clear, oblong softgel capsule containing pale yellow oil.
| Supplement Facts Servings per Carton: 30 | ||
|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains | %DV for Pregnant and Lactating Women | |
| Vitamin A (beta carotene) | 2850 IU | 36% |
| Vitamin C (ascorbic acid) | 120 mg | 200% |
| Vitamin D (cholecalciferol) | 840 IU | 210% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 3 mg | 18% |
| Vitamin B1 (thiamine mononitrate) | 1.8 mg | 106% |
| Vitamin B2 (riboflavin) | 4 mg | 200% |
| Niacinamide | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 50 mg | 2000% |
| Folic Acid | 1 mg | 125% |
| Vitamin B12 (cyanocobalamin) | 12 mcg | 150% |
| Calcium (calcium carbonate) | 219 mg | 17% |
| Iron (sodium iron EDTA & polysaccharide iron complex) | 27 mg | 150% |
| Magnesium (magnesium oxide) | 25 mg | 6% |
| Zinc (zinc oxide) | 25 mg | 167% |
| Copper (cupric oxide) | 2 mg | 100% |
| Iodine | 220 mcg | 147% |
Inactive Ingredients(Vena-Bal DHA Tablet): Microcrystalline Cellulose, Hypromellose, TriPotassium Citrate, Croscarmellose Sodium, Titanium Dioxide, Acacia, Citric Acid, Povidone K30, Stearic Acid, Magnesium Stearate, Polyethylene Glycol, Ethyl Cellulose, Talc, Fumed Silica, Polysorbate 80, FD&C Yellow #5 Lake, Mineral Oil, Hydroxypropyl Cellulose, Ascorbyl Palmitate, FD&C Yellow #6 Lake.
Each oblong, Enteric-coated DHA Softgel Capsule contains: Not less than 430 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), and DPA (docasapentaenoic acid) in approximately 628 mg of fish oil.
| OMEGA-3 FATTY ACIDS | |
| Total Omega-3 long-chain fatty acids | No less than 430 mg |
| As DHA | No less than 295 mg |
| As other omega-3 long-chain fatty acids | No less than 135 mg |
Inactive Ingredients (Enteric-coated DHA Softgel Capsule): Gelatin, Glycerin, Purified Water, Enteric Coating (Dewaxed Shellac USP, Sodium Aliginate, Ammonium Hydroxide, Glycerin, Acetylated Monoglycerides, Polysorbate 80, Potassium Sorbate, and Carnauba Wax)
Vena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Vena-Bal DHA is also useful in improving the nutritional status prior to conception.
This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.
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. |
THIS PRODUCT CONTAINS FISH OIL.
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alpha-linolenic acid (ALA), and docosahexaenoic acid (DHA)] from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Before, during and after pregnancy, One tablet and One enteric-coated softgel capsule taken by mouth daily, or as prescribed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
Vena-Bal DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply.
PRODUCT CODE: 13811-601-30
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Keep in a well-closed, light-resistant container as defined by the USP.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).
Rx Only
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalences.
Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872www.trigenlab.com
Rev. 04/13
13811-601-30
Rx Only
Vena-Bal DHA
Gluten-Free Prenatal
Multivitamin/Multimineral
TRIGEN
LABORATORIES
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-601-30 | EA - Each | 13811-601 | 25cffa82-2380-442c-8329-0567608ddd03 | 1 | 2013-07-02 |
| 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 | |
| Cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| Cupric Oxide | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Magnesium Oxide | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| Niacinamide | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| Omega-3 Fatty Acids | ACTIVE INGREDIENT | 71M78END5S | 1 | |
| Potassium Iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 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 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| IODIDE ION | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| Omega-3 Fatty Acids | ACTIVE MOIETY | 71M78END5S | 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 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | 1 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| DIACETYLATED MONOGLYCERIDES | INACTIVE INGREDIENT | 5Z17386USF | 1 | |
| Ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 1 | |
| FD&C Yellow No. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| Potassium Citrate Anhydrous | INACTIVE INGREDIENT | 86R1NVR0HW | 1 | |
| Potassium Sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| Povidone K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13811-601 | 13811-601-30 |
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 |
|---|---|---|---|---|---|---|
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / RECTAL | 7 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | ELIXIR / ORAL | 5.4 mg/5ml | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, CHEWABLE / ORAL | 24 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GEL / RECTAL | 348 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| Povidone K30 | POVIDONE K30 | U725QWY32X | PELLET / ORAL | 24 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| FD&C Yellow No. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUPPOSITORY / VAGINAL | NA | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / OPHTHALMIC | 0.05 %w/w | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| Carnauba Wax | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| Acacia | ACACIA | 5C5403N26O | SUSPENSION / ORAL | 2 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SWAB / TOPICAL | 0.05 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| FD&C Yellow No. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUSPENSION / ORAL | NA | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| Hydroxypropyl Cellulose (Type H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, CHEWABLE / ORAL | 10 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| Hydroxypropyl Cellulose (Type H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET / SUBLINGUAL | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| Povidone K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / VAGINAL | 28 mg | ||
| FD&C Yellow No. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE / ORAL | 652 mg | ||
| Hydroxypropyl Cellulose (Type H) | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 39.2 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg |
Adverse event summaries are temporarily unavailable. Other product information remains available.