Label: COMPLETE NATAL DHA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, cupric oxide, and doconexent kit
- NHRIC Code(s): 13811-010-30
- Packager: Trigen Laboratories, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated January 26, 2022
If you are a consumer or patient please visit this version.
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SUPPLEMENT FACTS
Other Ingredients:
Tablets: Microcrystalline Cellulose, Croscarmellose Sodium, Tripotassium Citrate, Coating (Hypromellose, Polyethylene Glycol, Polysorbate 80, Castor Oil), Acacia, Citric Acid, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid
Soft gelatin capsules: Bovine Gelatin, Glycerin, Water, and Ethyl Vanillin.
THIS PRODUCT CONTAINS FISH OIL (ANCHOVIES & SARDINES).
Complete Natal DHA is a multivitamin/multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.
- CONTRAINDICATIONS
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WARNINGS
Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
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.
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PRECAUTIONS
General: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Safety and effectiveness in elderly populations have not been established.
- DRUG INTERACTIONS
- ADVERSE REACTIONS
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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HEALTH CLAIM
KEEP OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-COMNDHA-00001-1 Rev. 01/2022
Manufactured for:
Trigen Laboratories, LLC
Alpharetta, GA 30005
www.trigenlab.com
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
COMPLETE NATAL DHA
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, cupric oxide, and doconexent kitProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-010 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:13811-010-30 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 30 Part 2 1 BLISTER PACK 30 Part 1 of 2 COMPLETE NATAL DHA
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, and cupric oxide tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 3000 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 120 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL- 30 mg Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.8 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 4 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Carbonate 200 mg Ferrous Bisglycinate (UNII: SFW1D987QV) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation 29 mg Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Oxide 25 mg Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 25 mg Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation 2 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) CASTOR OIL (UNII: D5340Y2I9G) Croscarmellose Sodium (UNII: M28OL1HH48) Hypromelloses (UNII: 3NXW29V3WO) Acacia (UNII: 5C5403N26O) Citric Acid Monohydrate (UNII: 2968PHW8QP) Povidone K30 (UNII: U725QWY32X) Magnesium Stearate (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Stearic acid (UNII: 4ELV7Z65AP) Polysorbate 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 06/01/2010 Part 2 of 2 COMPLETE NATAL DHA
doconexent capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 200 mg Inactive Ingredients Ingredient Name Strength GELATIN TYPE B BOVINE (200 BLOOM) (UNII: A7JR5F8DLH) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Ethyl Vanillin (UNII: YC9ST449YJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 06/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 06/01/2010 Labeler - Trigen Laboratories, LLC (830479668)