Label: OBTREX DHA COMBO PACK- docosahexaenoic acid, beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate kit
- NHRIC Code(s): 67555-143-60
- Packager: Pronova Corporation
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated February 6, 2023
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OBTREX DHA Softgels
Supplement Facts Serving Size: 1 Softgel / Servings Per Container: 30 Amount % Daily Per Serving Value DHA (docosahexaenoic acid) 350 mg * * % Daily Value not established. OTHER INGREDIENTS:
Gelatin, Glycerine, Purified Water, Sodium Alginate, Stearic Acid. This product contains purified fish oil.
OBTREX™ DHA Omega-3 Fatty Acids are manufactured under cGMP, CFIA and HACCP standards and are also in compliance with the Global Organization of DHA Omega-3 standards.
INDICATIONS:
OBTREX™ DHA combination pack is indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers. OBTREX™ DHA combination pack is also useful in improving nutritional status prior to conception.†
†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. - DOSAGE AND ADMINISTRATION:
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PRECAUTIONS:
Ingestion of more than 3 grams per day of omega-3 fatty acids, such as DHA (docosahexaenoic acid) has been shown to have potential anti-thrombotic effects, including increased bleeding times. Administration of OBTREX™ DHA Omega-3 Fatty Acids should be avoided in patients taking anticoagulants.
Sold in combination with OBTREX™ DHA Prenatals
- STORAGE:
- HEALTH CLAIM
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OBTREX DHA Caplets
Supplement Facts Serving Size: 1 Caplet / Servings Per Container: 30 Amount Per Serving
% Daily Value**
Vitamin A (as Beta Carotene) 810 mcg 62% Vitamin C (as Ascorbic Acid) 120 mg 100% Vitamin D (as Cholecalciferol) 10 mcg 67% Vitamin E (as dl-Alpha Tocopheryl Acetate) 8.1 mg 43% Thiamin (as Thiamine HCl) 3 mg 214% Riboflavin 3.4 mg 213% Niacin (as Niacinamide) 20 mg 111% Vitamin B6 (as Pyridoxine HCl) 40 mg 2000% Folate (as L-5-Methyltetrahydrofolate Calcium) 1700 mcg DFE 283% (1000 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) 12 mcg 429% Iron (as Carbonyl Iron) 29 mg 107% Magnesium (as Magnesium Oxide) 30 mg 8% Zinc (as Zinc Oxide) 25 mg 192% Selenium (as Sodium Selenate) 65mcg 93% * Daily Value (DV) for Pregnant and Lactating Women. OTHER INGREDIENTS:
Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium, Gelatin, Stearic Acid, Hypromellose, Maltodextrin, Crospovidone, Starch, Silica, Titanium Dioxide, Triacetin, Sucrose, Citric Acid, Magnesium Stearate, Sodium Lauryl Sulfate, Polyvinylpyrrolidone, Soy Polysaccharide, Mineral Oil, Riboflavin, FD&C Yellow #6 Lake, Sodium Ascorbate, Polyethylene Glycol, Trisodium Citrate, Tocopherols, Tricalcium Phosphate, Glycerol Monostearate, Triethyl Citrate, Ascorbyl Palmitate, Triglycerides, Sodium Benzoate, Polysorbate 80, Sorbic Acid and Talc. Contains soy.
DESCRIPTION:
OBTREX™ DHA combination pack is indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers.
OBTREX™ DHA combination pack is also useful in improving nutritional status prior to conception.†
†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. - DOSAGE AND ADMINISTRATION:
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WARNINGS
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient
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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. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
ADVERSE REACTIONS:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
- STORAGE:
- HEALTH CLAIM
- OBTREX DHA Combo Pack
- DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- HEALTH CLAIM
- Packaging
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INGREDIENTS AND APPEARANCE
OBTREX DHA COMBO PACK
docosahexaenoic acid, beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate kitProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:67555-143 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:67555-143-60 1 in 1 BOX Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 Part 2 1 BOTTLE 30 Part 1 of 2 OBTREX DHA SOFTGEL
docosahexaenoic acid capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 350 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) STEARIC ACID (UNII: 4ELV7Z65AP) FISH OIL (UNII: XGF7L72M0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/24/2023 Part 2 of 2 OBTREX DHA CAPLET
beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopheryl acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, l-5-methyltetrahydrofolate calcium, cyanocobalamin, carbonyl iron, magnesium oxide, zinc oxide, sodium selenate 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 810 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 8.1 mg THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 40 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1000 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 29 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SELENIUM 65 ug Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) STARCH, RICE (UNII: 4DGK8B7I3S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) SUCROSE (UNII: C151H8M554) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ) MINERAL OIL (UNII: T5L8T28FGP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SODIUM ASCORBATE (UNII: S033EH8359) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TOCOPHEROL (UNII: R0ZB2556P8) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ASCORBYL PALMITATE (UNII: QN83US2B0N) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBIC ACID (UNII: X045WJ989B) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/24/2023 Labeler - Pronova Corporation (111421496)