Document

DailyMed Label: Select-OB Plus DHA

Title
DailyMed Label: Select-OB Plus DHA
Date
2023
Document type
DailyMed Prescription
Name
Select-OB Plus DHA
Generic name
.BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, NIACINAMIDE, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, MAGNESIUM OXIDE, ZINC OXIDE, and DOCONEXANT
Manufacturer
Exeltis USA, Inc.
Product information
NDC: 0642-0075
Product information
NDC: 0642-0075
Description
Each SELECT-OB ® caplet contains: Vitamin A (as retinyl acetate & beta carotene) 510 mcg RAE (1700 IU) Vitamin C (as ascorbic acid) 60 mg Vitamin D (as cholecalciferol) 10 mcg (400 IU) Vitamin E (as dl-alpha tocopheryl acetate) 13.5 mg (30 IU) Thiamin (Vitamin B1 as thiamine mononitrate) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg NE Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as folic acid) 1700 mcg DFE Vitamin B12 (as cyanocobalamin) 5 mcg Iron (as polysaccharide iron complex) 29 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 15 mg Each softgel capsule contains: Docosahexaenoic acid (DHA) (from natural algal oil) 250 mg Other Ingredients in Select-OB ® caplet: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1 / Aluminum Lake, FD&C Blue #2 / Aluminum Lake. Contains: Soy Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.
Indications
Select-OB+DHA ® is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.* Select-OB+DHA ® does not contain fish, fish oils, fish proteins or fish byproducts.
Dosage
Before, during and after pregnancy, chew or swallow one blue Select OB ® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.
Contraindications
Select-OB+DHA ® is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitaminB12).
Adverse reactions
Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Select-OB+DHA
Drug interactions
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions.
How supplied
Select-OB+DHA ® is available as a light blue caplet debossed EV0077 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 SELECT-OB ® caplets and 6 DHA softgel capsules each) (0642-0075-30) and as professional samples (0642-0075-03). Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.
Package label
0642-0075-30 Select-OB+DHA ® Prenatal Supplement with DHA Berry flavored BLUE Select-OB ® Caplet can be chewed or swallowed DHA Softgel Capsule from natural source DHA Smaller DHA Softgel DOES NOT CONTAIN FISH OIL R X Unit Dose Pack 30 Caplets and 30 Softgel Capsules U.S. Patented PRINCIPAL DISPLAY PANEL - Kit Carton

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1 product

Organization
Exeltis USA, Inc.